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GRISEOFULVIN suspension


  1. Description
  2. Clinical Pharmacology
  3. Indications And Usage
  4. Contraindications
  5. Warnings
  6. Precautions
  7. Adverse Reactions
  8. Overdosage
  9. Dosage And Administration
  10. How Supplied
  11. Package Label.principal Display Panel
  12. Description
  13. Indications And Usage
  14. Contraindications
  15. Warnings
  16. Precautions
  17. Drug Interactions
  18. Adverse Reactions
  19. Dosage And Administration
  20. How Supplied
  21. Principal Display Panel - 5 Ml Label

Description  

Griseofulvin microsize contains griseofulvin microsize for oral administration. The active ingredient, griseofulvin, is a fungistatic antibiotic, derived from a species of Penicillium. The chemical name of griseofulvin is 7-chloro-2 ,4,6-trimethoxy-6 -methylspiro[benzofuran - 2(3H),1 -[2]cyclohexane]-3-4 -dione. Its structural formula is:

structure

C17H17ClO6 M.W. = 352.77

Griseofulvin occurs as a white to creamy white, bitter tasting powder which is very slightly soluble in water and sparingly soluble in alcohol. Griseofulvin microsize contains particles of approximately 2 to 4 m in diameter.

Griseofulvin oral suspension, USP is an orange colored suspension. Each 5 mL of Griseofulvin Oral Suspension, USP contains 125 mg of griseofulvin microsize and also contains alcohol 0.2%, artificial orange vanilla flavor, docusate sodium, FD&C Red No. 40, FD&C Yellow No. 6, magnesium aluminum silicate, menthol, methylparaben, propylene glycol, propylparaben, saccharin sodium, simethicone emulsion, sodium alginate, sucrose, and purified water.

Clinical Pharmacology 

Griseofulvin Oral Suspension acts systemically to inhibit the growth of Trichophyton, Microsporum, and Epidermophyton genera of fungi. Fungistatic amounts are deposited in the keratin, which is gradually exfoliated and replaced by noninfected tissue.

Griseofulvin absorption from the gastrointestinal tract varies considerably among individuals, mainly because of insolubility of the drug in aqueous media of the upper G.I. tract. The peak serum level found in fasting adults given 0.5 gm occurs at about four hours and ranges between 0.5 and 2.0 mcg/mL.

It should be noted that some individuals are consistently "poor absorbers" and tend to attain lower blood levels at all times. This may explain unsatisfactory therapeutic results in some patients. Better blood levels can probably be attained in most patients if administered after a meal with a high fat content.

Indications And Usage  

Griseofulvin Oral Suspension USP, is indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely: Tinea corporis

Tinea pedis
Tinea cruris
Tinea barbae
Tinea capitis

Tinea unguium when caused by one or more of the following species of fungi:

Epidermophyton floccosum
Microsporum audouinii
Microsporum canis
Microsporum gypseum
Trichophyton crateriform
Trichophyton gallinae
Trichophyton interdigitalis
Trichophyton megnini
Trichophyton mentagrophytes
Trichophyton rubrum
Trichophyton schoenleini
Trichophyton sulphureum
Trichophyton tonsurans
Trichophyton verrucosum

Note: Prior to therapy, a dermatophyte should be identified as responsible for the infection.

Prior to initiating treatment, appropriate specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis.

Griseofulvin is not effective in the following:

Bacterial infections
Candidiasis (Moniliasis)
Histoplasmosis
Actinomycosis
Sporotrichosis
Chromoblastomycosis
Coccidioidomycosis
North American Blastomycosis
Cryptococcosis (Torulosis)
Tinea versicolor
Nocardiosis

The use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone.

Contraindications  

Griseofulvin is contraindicated in patients with porphyria or hepatocellular failure, and in individuals with a history of hypersensitivity to griseofulvin.

Griseofulvin may cause fetal harm when administered to a pregnant woman. Two published cases of conjoined twins have been reported in patients taking griseofulvin during the first trimester of pregnancy, therefore, griseofulvin is contraindicated in women who are or may become pregnant during treatment. Women taking estrogen-containing oral contraceptives may be at increased risk of becoming pregnant while on griseofulvin (see also PRECAUTIONS, Drug Interactions). If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Although no direct causal relationship has been established, spontaneous abortion has been reported rarely coincident with the use of griseofulvin. Note: The Maximum Recommend Human Dose (MRHD) was set at 500 mg/day for the multiple of human exposure calculations performed in this label. If higher doses than 500 mg/day were used clinically, then the multiple of human exposure would be correspondingly reduced for that dose. For example, if a 1,000 mg/day dose was administered to an individual, then the multiple of human exposure would be reduced by a factor of 2.

Griseofulvin has been shown to be embryotoxic and teratogenic in pregnant rats when given at a daily oral dose of 250 mg/kg/day [4X the Maximum Recommended Human Dose (MRHD) based on Body Surface Area (BSA)]. Griseofulvin also has been shown to be embryotoxic and teratogenic in pregnant cats treated weekly with griseofulvin at doses of 500 to 1,000 mg/week. There are reports of teratogenicity in a Golden Retriever when doses of 750 mg/day [1.2X the MRHD based on BSA] were administered for four weeks prior to and throughout the pregnancy, and in a study in which beagles were administered 35 mg/kg/day [1.9X the MRHD based on BSA] for intervals from one week up to the entire gestation period. Teratogenicity was also seen in mice when griseofulvin was administered in doses equivalent to 5g/kg/day [40X the MRHD based on BSA] for 2 consecutive days at various stages of the pregnancy.

Warnings  

Prophylactic Usage:
Safety and efficacy of griseofulvin for prophylaxis of fungal infections have not been established.

Serious Skin Reactions:
Severe skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis) and erythema multiforme have been reported with griseofulvin use. These reactions may be serious and may result in hospitalization or death. If severe skin reactions occur, griseofulvin should be discontinued (see ADVERSE REACTIONS section).

Hepatotoxicity:
Elevations in AST, ALT, bilirubin, and jaundice have been reported with griseofulvin use. These reactions may be serious and may result in hospitalization or death. Patients should be monitored for hepatic adverse events and discontinuation of griseofulvin considered if warranted (see ADVERSE REACTIONS section).

Precautions  

General:
Patients on prolonged therapy with any potent medication should be under close observation. Periodic monitoring of organ system function, including renal, hepatic and hematopoietic, should be done.

Since griseofulvin is derived from species of penicillin, the possibility of cross sensitivity with penicillin exists; however, known penicillin-sensitive patients have been treated without difficulty.

Lupus erythematosus, lupus-like syndromes or exacerbation of existing lupus erythematosus have been reported in patients receiving griseofulvin.

Since a photosensitivity reaction is occasionally associated with griseofulvin therapy, patients should be warned to avoid exposure to intense or prolonged natural or artificial sunlight.

Drug Interactions:

Griseofulvin has been reported in the literature to interfere with the metabolism of various compounds. Whether this is due to a P-450 mediated enzyme induction effects on sulfurtransferase and/or glucotransferase activity, or some other mechanism is unknown.

Griseofulvin decreases the activity of warfarin-type anticoagulants, so that patients receiving these drugs concomitantly may require dosage adjustment of the anticoagulant during and after griseofulvin therapy.

Griseofulvin may enhance the hepatic metabolism of estrogens, including the estrogen component of oral contraceptives, thereby reducing the effectiveness of contraception and causing menstrual irregularities. Therefore, an alternate or second form of birth control may be indicated during periods of concurrent use (see also CONTRAINDICATIONS).

Cyclosporine levels may be reduced when administered concomitantly with griseofulvin, resulting in a decrease in the pharmacologic effects of cyclosporine.

Serum salicylate concentrations may be decreased when griseofulvin is given concomitantly with salicylates.

Barbiturates usually depress griseofulvin activity by decreasing plasma levels and concomitant administration may require a dosage adjustment of the antifungal agent.

Nausea, vomiting, flushing, tachycardia, and severe hypotension have been reported following alcohol ingestion during griseofulvin therapy.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

In subacute toxicity studies, orally administered griseofulvin produced hepatocellular necrosis in mice, but this has not been seen in other species. Chronic feeding of griseofulvin, at levels ranging from 0.5 to 2.5% of the diet, resulted in the development of liver tumors in several strains of mice, particularly in males. Smaller particle sizes resulted in an enhanced effect. Lower oral-dosage levels have not been tested. Subcutaneous administration of relatively small doses of griseofulvin once a week during the first three weeks of life has also been reported to induce hepatomata in mice. Thyroid tumors, mostly adenomas but some carcinomas, have been reported in male rats receiving griseofulvin at levels of 2.0%, 1.0%, and 0.2% of the diet, and in female rats receiving the two higher dose levels. Studies in other animal species were inadequate assessments of tumorigenicity.

Disturbances in porphyrin metabolism have been reported in griseofulvin-treated laboratory animals. Griseofulvin has been reported to have a colchicine-like effect on mitosis and was cocarcinogenic with methylcholanthrene in cutaneous tumor induction in laboratory animals. Griseofulvin interferes with chromosomal distribution during cell division, causing aneuploidy in plant and mammalian cells. These effects have been demonstrated in vitro at concentrations that may be achieved in the serum with the recommended therapeutic dosage.

Suppression of spermatogenesis has been reported to occur in rats and sperm abnormalities have been observed in griseofulvin treated mice, but these were not detected in man. Male patients should wait at least six months after completing griseofulvin therapy before fathering a child.

Pregnancy:

Teratogenic Effects: Pregnancy Category X: See CONTRAINDICATIONS and PRECAUTIONS, Drug Interactions

Nursing Mothers:

It is not known if griseofulvin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for griseofulvin in animal studies (see PRECAUTIONS, Carcinogenesis, Mutagenesis, Impairment of Fertility), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in pediatric patients 2 years of age and younger have not been established. Safety in pediatric patients older than 2 years of age at dosages greater than 10 mg/kg daily has not been established.

Adverse Reactions  

There have been postmarketing reports of severe skin and hepatic adverse events associated with griseofulvin use (see WARNINGS section).

When adverse reactions occur, they are most commonly of the hypersensitivity type, such as skin rashes, urticaria, and rarely, angioneurotic edema, and erythema multiforme. These may necessitate withdrawal of therapy and appropriate countermeasures. Peripheral neuropathy and paresthesias of the hands and feet have been reported and may be related to treatment duration. Most patients treated with griseofulvin for less than six months experienced improvement or resolution of their neuropathy upon withdrawal of the griseofulvin. Other side effects reported occasionally are oral thrush, nausea, vomiting, epigastric distress, diarrhea, headache, fatigue, dizziness, insomnia, mental confusion and impairment of performance of routine activities.

Proteinuria, nephrosis (sometimes associated with existing systemic lupus erythematosus), leukopenia, coagulopathy, hepatitis, elevated liver enzymes, hyperbilirubinemia, and GI bleeding have been reported rarely. Administration of the drug should be discontinued if granulocytopenia occurs.

To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

Overdosage  

There is limited experience on overdose with griseofulvin. In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures as required.

Dosage And Administration  

Accurate diagnosis of the infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium.

Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. Representative treatment periods are tinea capitis, 4 to 6 weeks; tinea corporis, 2 to 4 weeks; tinea pedis, 4 to 8 weeks; tinea unguium-depending on rate of growth-fingernails, at least 4 months; toenails, at least 6 months.

General measures in regard to hygiene should be observed to control sources of infection or reinfection. Concomitant use of appropriate topical agents is usually required, particularly in treatment of tinea pedis. In some forms of tinea pedis, yeasts and bacteria may be involved as well as dermatophytes. Griseofulvin will not eradicate these associated bacterial or yeast infections.

Adults: 0.5 g daily (125 mg four times a day, 250 mg twice a day, or 500 mg/day). Patients with less severe or 300 extensive infections may require less, whereas those with widespread lesions may require a starting dose of 0.75 g to 1.0 g/day. This may be reduced gradually to 0.5 g or less after a response has been noted. In all cases, the dosage should be individualized.

Pediatric patients (older than 2 years): A dosage of 10 mg/kg daily is usually adequate (pediatric patients from 30 to 50 lbs, 125 mg to 250 mg daily; pediatric patients over 50 lbs, 250 mg to 500 mg daily, in divided doses). Dosage should be individualized, as with adults. Clinical relapse will occur if the medication is not continued until the infecting organism is eradicated.

Safety is not established at higher doses than recommended.

How Supplied  

Griseofulvin Oral Suspension USP (microsize), 125 mg per 5 mL is an orange-vanilla flavored suspension available in bottles of 4 fl oz (120 mL) NDC 0472-0013-04.

Dispense Griseofulvin Oral Suspension in a tight, light-resistant container as defined in the USP.

Store at 20 -25 C (68 -77 F) [see USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Manufactured by:
G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Rev, A 12/2018

Package Label.principal Display Panel  

Actavis

NDC 0472-0013-04

Rx Only

Griseofulvin Oral Suspension USP (microsize)

125 mg/5 mL

Each 5 mL (one teaspoonful) contains 125 mg griseofulvin in a palatable suspension, colored orange. Also contains alcohol 0.2%.

SHAKE BEFORE USING

4 FL OZ (120 mL)

4 FL oz
GRISEOFULVIN
griseofulvin suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0472-0013
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GRISEOFULVIN (UNII: 32HRV3E3D5) (GRISEOFULVIN - UNII:32HRV3E3D5) GRISEOFULVIN 125 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL (UNII: 3K9958V90M)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
Product Characteristics
Color Score
Shape Size
Flavor ORANGE, VANILLA Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0472-0013-04 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/26/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065394 07/26/2007
Labeler - Actavis Pharma, Inc. (119723554)

Revised: 12/2018 Actavis Pharma, Inc.

Description 

Griseofulvin is an antibiotic derived from a species of Penicillium. Each 5 mL of Griseofulvin Oral Suspension (microsize) contains 125 mg of griseofulvin microsize and also contains alcohol 0.2%, docusate sodium, FD&C Red No. 40, FD&C Yellow No. 6, flavors, magnesium aluminum silicate, menthol, methylparaben, propylene glycol, propylparaben, saccharin sodium, simethicone emulsion, sodium alginate, sucrose, and purified water.

Indications And Usage 

Major indications for Griseofulvin Oral Suspension are:

Tinea capitis (ringworm of the scalp)

Tinea corporis (ringworm of the body)

Tinea pedis (athlete's foot)

Tinea unguium (onychomycosis; ringworm of the nails)

Tinea cruris (ringworm of the thigh)

Tinea barbae (barber's itch)

Griseofulvin Oral Suspension inhibits the growth of those genera of fungi that commonly cause ringworm infections of the hair, skin, and nails, such as:

Trichophyton rubrum

Trichophyton tonsurans

Trichophyton mentagrophytes

Trichophyton interdigitalis

Trichophyton verrucosum

Trichophyton sulphureum

Trichophyton schoenleini

Microsporum audouini

Microsporum canis

Microsporum gypseum

Epidermophyton floccosum

Trichophyton megnini

Trichophyton gallinae

Trichophyton crateriform

Note: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical anti-fungal agents alone.

It is not effective in:

Bacterial infections

Candidiasis (Moniliasis)

Histoplasmosis

Actinomycosis

Sporotrichosis

Chromoblastomycosis

Coccidioidomycosis

North American Blastomycosis

Cryptococcosis (Torulosis)

Tinea versicolor

Nocardiosis

Contraindications 

This drug is contraindicated in patients with porphyria, hepatocellular failure, and in individuals with a history of hypersensitivity to griseofulvin.

Two cases of conjoined twins have been reported in patients taking griseofulvin during the first trimester of pregnancy. Griseofulvin should not be prescribed to pregnant patients.

Warnings 

Prophylactic Usage

Safety and efficacy of prophylactic use of Griseofulvin Oral Suspension has not been established.

Chronic feeding of griseofulvin, at levels ranging from 0.5-2.5% of the diet, resulted in the development of liver tumors in several strains of mice, particularly in males. Smaller particle sizes result in an enhanced effect. Lower oral dosage levels have not been tested. Subcutaneous administration of relatively small doses of griseofulvin once a week during the first three weeks of life has also been reported to induce hepatomata in mice.Although studies in other animal species have not yielded evidence of tumorigenicity, these studies were not of adequate design to form a basis for conclusions in this regard.

In subacute toxicity studies, orally administered griseofulvin produced hepatocellular necrosis in mice, but this has not been seen in other species. Disturbances in porphyrin metabolism have been reported in griseofulvin-treated laboratory animals. Griseofulvin has been reported to have a colchicine-like effect on mitosis and cocarcinogenicity with methylcholanthrene in cutaneous tumor induction in laboratory animals.

Reports of animal studies in the Soviet literature state that a griseofulvin preparation was found to be embryotoxic and teratogenic on oral administration to pregnant Wistar rats. Rat reproduction studies done in the United States and Great Britain were inconclusive in this regard. Pups with abnormalities have been reported in the litters of a few bitches treated with griseofulvin. Because the potential for adverse effects on the human fetus cannot be ruled out, additional contraceptive precautions should be taken during treatment with griseofulvin and for a month after termination of treatment. Griseofulvin Oral Suspension should not be prescribed to women intending to become pregnant within one month following cessation of therapy.

Suppression of spermatogenesis has been reported to occur in rats but investigation in man failed to confirm this. Griseofulvin interferes with chromosomal distribution during cell division, causing aneuploidy in plant and mammalian cells. These effects have been demonstrated in vitro at concentrations that may be achieved in the serum with the recommended therapeutic dosage.

Since griseofulvin has demonstrated harmful effects in vitro on the genotype in bacteria, plants, and fungi, males should wait at least six months after completing griseofulvin therapy before fathering a child.

Precautions 

Patients on prolonged therapy with any potent medication should be under close observation. Periodic monitoring of organ system function, including renal, hepatic and hemopoietic, should be done.

Since griseofulvin is derived from species of penicillin, the possibility of cross sensitivity with penicillin exists; however, known penicillin-sensitive patients have been treated without difficulty.

Since a photosensitivity reaction is occasionally associated with griseofulvin therapy, patients should be warned to avoid exposure to intense natural or artificial sunlight. Should a photosensitivity reaction occur, lupus erythematosus may be aggravated.

Drug Interactions 

Patients on warfarin-type anticoagulant therapy may require dosage adjustment of the anticoagulant during and after griseofulvin therapy. Concomitant use of barbiturates usually depresses griseofulvin activity and may necessitate raising the dosage.

The concomitant administration of griseofulvin has been reported to reduce the efficacy of oral contraceptives and to increase the incidence of breakthrough bleeding.

Adverse Reactions 

When adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, urticaria and rarely, angioneurotic edema or erythema multiforme-like drug reaction, and may necessitate withdrawal of therapy and appropriate countermeasures. Paresthesias of the hands and feet have been reported rarely after extended therapy. Other side effects reported occasionally are oral thrush, nausea, vomiting, epigastric distress, diarrhea, headache, fatigue, dizziness, insomnia, mental confusion and impairment of performance of routine activities.

Proteinuria and leukopenia have been reported rarely. Administration of the drug should be discontinued if granulocytopenia occurs.

When rare, serious reactions occur with griseofulvin, they are usually associated with high dosages, long periods of therapy, or both.

Dosage And Administration 

Accurate diagnosis of the infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium.

Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. Representative treatment periods are tinea capitis, 4 to 6 weeks; tinea corporis, 2 to 4 weeks; tinea pedis, 4 to 8 weeks; tinea unguium depending on rate of growth fingernails, at least 4 months; toenails, at least 6 months.

General measures in regard to hygiene should be observed to control sources of infection or reinfection. Concomitant use of appropriate topical agents is usually required, particularly in treatment of tinea pedis since in some forms of athlete's foot, yeasts and bacteria may be involved. Griseofulvin will not eradicate the bacterial or monilial infection.

Adults

A daily dose of 500 mg will give a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis.

For those fungus infections more difficult to eradicate such as tinea pedis and tinea unguium, a daily dose of 1.0 gram is recommended.

Children

Approximately 5 mg per pound of body weight per day is an effective dose for most children. On this basis the following dosage schedule for children is suggested:

Children weighing 30 to 50 pounds 125 mg to 250 mg daily. Children weighing over 50 pounds 250 mg to 500 mg daily.

How Supplied 

Griseofulvin Oral Suspension 125 mg per 5 mL in bottles of 4 fl oz (120 mL) (NDC 54868-5234-0).

Dispense Griseofulvin Oral Suspension in a tight, light-resistant container as defined in the USP.

STORE AT ROOM TEMPERATURE

For more information call 1-800-510-0383.

Manufactured by:
Ortho-McNeil Pharmaceutical, Inc.
Raritan, NJ 08869

Distributed by:
Patriot Pharmaceuticals, LLC
Plymouth Meeting, PA 19462

Printed in U.S.A., OMP 2005

Revised July 2005
10094000


Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK 74146

Principal Display Panel - 5 Ml Label 

Griseofulvin
Oral Suspension
(microsize)
125 mg/5 mL

Each 5 mL (one teaspoonful) contains 125 mg
Griseofulvin microsize in a palatable suspension,
colored orange. Also contains alcohol 0.2%.

Rx Only.

Store at room temperature.

SHAKE BEFORE USING

Pharmacist: This product is protected by a tamper-
resistant seal around the neck opening. If the seal
has been broken or is removed, do not use the
product. Return the product to place of purchase.

4 fl oz (120 mL)

image of package label

GRISEOFULVIN
griseofulvin suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5234(NDC:10147-0810)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GRISEOFULVIN (UNII: 32HRV3E3D5) (GRISEOFULVIN - UNII:32HRV3E3D5) GRISEOFULVIN 125 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL (UNII: 3K9958V90M)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54868-5234-0 120 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062483 01/16/2006
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Business Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 10/2010 Physicians Total Care, Inc.



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