ATROPINE SULFATE injection

1. No Title 1572547537
2. No Title 1572549688
3. No Title 1572553075
4. No Title 1572555571
5. Principal Display Panel - Serialized Box Labeling
6. Indications And Usage
7. Dosage And Administration
8. Sample Package Label
9. No Title 1572449940
10. Vial Label
11. Package: Outer Label
12. No Title 1572450354
13. Principal Display Panel
14. Serialization Image
15. No Title 1572450977
16. Cllnical Pharmacology
17. Principle Display Panel: Vial Label
18. Principle Display Panel:
19. No Title 1572452419
20. Spl Unclassified
21. Description
22. Clinical Pharmacology
23. Indications & Usage
24. Contraindications
25. Warnings
26. Precautions
27. Adverse Reactions
28. Overdosage
29. Dosage & Administration
30. How Supplied
31. Principal Display Panel, Vial
32. Principal Display Panel, Serialized Vial

No Title 1572547537 ⮝

ATROPINE SULFATE
INJECTION, USP

No Title 1572549688 ⮝

FOR IM, IV OR SC USE

RX only

No Title 1572553075 ⮝

FOR IM, IV OR SC USE

RX only

No Title 1572555571 ⮝

ATROPINE SULFATE
INJECTION, USP

Principal Display Panel - Serialized Box Labeling ⮝

ATROPINE SULFATE atropine sulfate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1378(NDC:76329-3339) Route of Administration PARENTERAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) ATROPINE SULFATE 0.1 mg in 1 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51662-1378-1 1 in 1 BOX 10/15/2019 1 10 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/15/2019

Labeler - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Registrant - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Establishment
Name	Address	ID/FEI	Business Operations
HF Acquisition Co LLC, DBA HealthFirst		045657305	relabel(51662-1378)

Revised: 10/2019 Document Id: 94ff6d60-1af1-2638-e053-2a95a90ad39b 34391-3 Set id: 94ff6d60-1af0-2638-e053-2a95a90ad39b Version: 1 Effective Time: 20191015 HF Acquisition Co LLC, DBA HealthFirst

Indications And Usage ⮝

Atropine Sulfate Injection, USP, may be given parenterally as a pre-anesthetic medication in surgical patients to reduce salivation and bronchial secretions. It may also be used to suppress vagal activity associated with the use of halogenated hydrocarbons during inhalation anesthesia and reflex excitation arising from mechanical stimulation during surgery.

The antispasmodic action of atropine is useful in pylorospasm and other spastic conditions of the gastrointestinal tract. For ureteral and biliary colic, atropine concomitantly with morphine may be indicated.

Atropine relaxes the upper GI tract and colon during hypotonic radiography.

In poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare nerve gases, large doses of atropine relieve the muscarine-like symptoms and some of the central nervous system manifestations. It is also used as an antidote for mushroom poisoning due to muscarine in certain species such as Amanita muscaria.

Dosage And Administration ⮝

Usual adult dosage:
Antimuscarinic: Intramuscular, intravenous, or subcutaneous, 400 to 600 g (0.4 to 0.6 mg) every four to six hours.
Arrhythmias: Intravenous, 400 g (0.4 mg) to 1 mg every one to two hours as needed, up to a maximum of 2 mg.
Gastrointestinal radiography: Intramuscular, 1 mg.
Preanesthesia (antisialagogue): Intramuscular, 200 to 600 g (0.2 to 0.6 mg) one-half to one hour before surgery.
Cholinergic adjunct (curariform block): Intravenous, 600 g (0.6 mg) to 1.2 mg administered a few minutes before or concurrently with 500 g (0.5 mg) to 2 mg of neostigmine methylsulfate, using separate syringes.
Antidote (to cholinesterase inhibitors): Intravenous, 2 to 4 mg initially, then 2 mg repeated every five to ten minutes until muscarinic symptoms disappear or signs of atropine toxicity appear.
Antidote (to muscarine in mushroom poisoning): Intramuscular or intravenous, 1 to 2 mg every hour until respiratory effects subside.
Antidote (to organophosphate pesticides): Intramuscular or intravenous 1 to 2 mg, repeated in twenty to thirty minutes as soon as cyanosis has cleared. Continue dosage until definite improvement occurs and is maintained, sometimes for two days or more.

Usual pediatric dosage
Antimuscarinic: Subcutaneous, 10 g (0.01 mg) per kg of body weight, not to exceed 400 g (0.4 mg), or 300 g (0.3 mg) per square meter of body surface, every four to six hours.
Arrhythmias: Intravenous, 10 to 30 g (0.01 to 0.03 mg) per kg of body weight.
Preanesthesia (antisialagogue): or
Preanesthesia (antiarrhythmic): Subcutaneous
Children weighing up to 3 kg: 100 g (0.1 mg).
Children weighing 7 to 9 kg: 200 g (0.2 mg).
Children weighing 12 to 16 kg: 300 g (0.3 mg).
Children weighing 20 to 27 kg: 400 g (0.4 mg).
Children weighing 32 kg: 500 g (0.5 mg).
Children weighing 41 kg; 600 g (0.6 mg).
Antidote (to cholinesterase inhibitors): Intravenous or intramuscular, 1 mg initially, then 0.5 to 1 mg every five to ten minutes until muscarinic symptoms disappear or signs of atropine toxicity appear.

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Sample Package Label ⮝

ATROPINE SULFATE atropine sulfate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52584-029(NDC:0641-6006) Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Atropine Sulfate (UNII: 03J5ZE7KA5) (Atropine - UNII:7C0697DR9I) Atropine Sulfate 0.4 mg in 1 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52584-029-01 1 in 1 BAG 05/08/2012 1 20 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/08/2012

Labeler - General Injectables & Vaccines, Inc (108250663)

Revised: 11/2018 Document Id: dd7b0d98-fda6-4d4a-bb58-830dd3a93821 34391-3 Set id: baf1529e-737d-4cbc-9111-6e5d89525051 Version: 3 Effective Time: 20181109 General Injectables & Vaccines, Inc

No Title 1572449940 ⮝

FOR IM, IV OR SC USE

RX only

Vial Label ⮝

Atropine Sulfate Injection, USP

8 mg/20 mL (0.4 mg/mL)

1- 20 mL Multiple Dose Vial

Package: Outer Label ⮝

NDC 71872-7037-1

Atropine Sulfate Injection, USP

8 mg/20 mL

1 - 20 mL Vial

FOR IM, IV OR SC USE.

Rx Only

ATROPINE SULFATE atropine sulfate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71872-7037(NDC:0641-6006) Route of Administration INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) ATROPINE SULFATE 0.4 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg in 1 mL BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg in 1 mL WATER (UNII: 059QF0KO0R) SULFURIC ACID (UNII: O40UQP6WCF)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71872-7037-1 1 in 1 BAG 02/19/2018 1 20 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/1971

Labeler - Medical Purchasing Solutions, LLC (601458529)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Purchasing Solutions, LLC		601458529	repack(71872-7037)

Revised: 5/2018 Document Id: 6bb51b79-ae87-aebf-e053-2991aa0a8d33 34391-3 Set id: 6bb51b79-ae86-aebf-e053-2991aa0a8d33 Version: 2 Effective Time: 20180508 Medical Purchasing Solutions, LLC

No Title 1572450354 ⮝

FOR IM, IV OR SC USE

RX only

Principal Display Panel ⮝

Atropine Sulfate Injection, USP
8 mg/20 mL (0.4 mg/mL)
20 mL Multiple Dose Vial
NDC 0641-6006-01

Atropine Sulfate Injection, USP
8 mg/20 mL (0.4 mg/mL)
10 x 20 mL Multiple Dose Vials
NDC 0641-6006-10

Serialization Image ⮝

ATROPINE SULFATE atropine sulfate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6006 Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) ATROPINE SULFATE 0.4 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg in 1 mL BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg in 1 mL WATER (UNII: 059QF0KO0R) SULFURIC ACID (UNII: O40UQP6WCF)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0641-6006-10 10 in 1 CARTON 01/01/1971 1 NDC:0641-6006-01 20 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1971

Labeler - West-Ward Pharmaceuticals Corp. (946499746)

Revised: 12/2018 Document Id: 1f855c97-dc00-43ff-9333-19105691b909 34391-3 Set id: 5d45eb2f-b964-4f64-b277-eef807520466 Version: 2 Effective Time: 20181210 West-Ward Pharmaceuticals Corp.

No Title 1572450977 ⮝

ATROPINE SULFATE
INJECTION, USP

Cllnical Pharmacology ⮝

Atropine inhibits the muscarinic actions of acetylcholine at postganglionic parasympathetic neuroeffector sites including smooth muscle, secretory glands and CNS sites. Large doses may block nicotinic receptors at the autonomic ganglia and at the neuromuscular junction.

Specific anticholinergic responses are dose-related. Small doses of atropine inhibit salivary and bronchial secretions and sweating; moderate doses dilate the pupil, inhibit accommodation and increase the heart rate (vagolytic effect); larger doses will decrease motility of the GI and urinary tracts; very large doses will inhibit gastric acid secretion.

Principle Display Panel: Vial Label ⮝

Rx Only

FOR I.V. USE / SEE INSERT

SINGLE DOSE

NO PRESERVATIVE ADDED

IMS, LIMITED

So. El Monte, CA 91733, U.S.A.

7633390B 7-11

10 mL 1 mg 0.1 mg/mL

ATROPINE SULFATE INJECTION, USP

Approx. 0 1 2 3 4 5 6 7 8 9

mg/mL 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9

Principle Display Panel: ⮝

Luer-Lock Prefilled Syringe

Rx Only

NDC 71872-7017-1

ATROPINE SULFATE INJ. USP (0.1 mg/mL)

1 mg per 10 mL

FOR INTRAVENOUS USE

ANTIMUSCARINIC

Single use, do not reuse or resterilize.

ATROPINE SULFATE atropine sulfate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71872-7017(NDC:76329-3339) Route of Administration PARENTERAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) ATROPINE SULFATE 0.1 mg in 1 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71872-7017-1 1 in 1 BAG 02/28/2018 1 10 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2000

Labeler - Medical Purchasing Solutions, LLC (601458529)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Purchasing Solutions, LLC		601458529	repack(71872-7017)

Revised: 3/2018 Document Id: 6672ca9c-2f71-be41-e053-2a91aa0a0636 34391-3 Set id: 6672ca9c-2f70-be41-e053-2a91aa0a0636 Version: 1 Effective Time: 20180302 Medical Purchasing Solutions, LLC

No Title 1572452419 ⮝

ATROPINE SULFATE
INJECTION, USP

Spl Unclassified ⮝

FOR IM, IV OR SC USE

RX only

Description ⮝

Atropine is chemically 1 H, 5 H - Tropan-3 -ol ( ) -tropate (ester), with the following structural formula:

Atropine rarely occurs as such in any of the plants and has been prepared by synthesis. It is usually employed in the form of atropine sulfate (the sulfate [2:1] monohydrate salt of atropine), which has much greater solubility in water.

Atropine Sulfate Injection, USP, is a sterile aqueous solution of atropine sulfate. Each mL contains atropine sulfate, 0.1 mg; sodium chloride, 8.8 mg, for isotonicity; citric acid, 0.63 mg, and sodium citrate, 0.29 mg, as buffers. May contain additional citric acid and/or sodium citrate for pH adjustment (3.0-6.5). The air above the liquid in the container has been displaced by nitrogen gas.

Clinical Pharmacology ⮝

The most important therapeutic action of atropine is the inhibition of smooth muscle and glands innervated by postganglionic cholinergic nerves. It also has central nervous system activity, which may be stimulating or depressing depending upon the dose.
Following the administration of usual clinical doses, atropine produces stimulation of the medulla and higher cerebral centers. This effect is manifested by mild central vagal excitation and moderate respiratory stimulation. Atropine sulfate also acts peripherally as a competitive antagonist of the muscarinic actions of acetylcholine. It does not prevent the release of acetylcholine but antagonizes the effect of acetylcholine on the effector cells.
These actions include vasodilation, drying of the mouth, an increase in the pulse rate, inhibition of contractions of the gastrointestinal tract, ureter, and bladder, and reduction of salivary, bronchial, gastric and sweat gland secretions. Following clinical and larger doses, atropine sulfate causes dilation of the pupils and paralysis of accommodation and, in narrow-angle glaucoma, can increase intraocular pressure.

Indications & Usage ⮝

Atropine sulfate is given parenterally as a preanesthetic medication to decrease salivation and bronchial secretions. It is useful in pylorospasm and other spastic conditions of the gastrointestinal tract. For ureteral and biliary colic, atropine sulfate given with morphine may be indicated. Atropine sulfate is indicated for relaxation of the upper gastrointestinal tract and colon during hypotonic radiography.
Atropine is used as an antidote for pilocarpine, physostigmine, isoflurophate, choline esters, certain species of aminata and in poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare nerve gases . Large doses relieve the muscarine-like symptoms and some of the central nervous system manifestations.

Contraindications ⮝

Atropine Sulfate is contraindicated in patients with a history of hypersensitivity to this drug.

Ocular: Narrow-angle glaucoma; adhesions (synechiae) between the iris and lens of the eye.
Cardiovascular: Tachycardia; unstable cardiovascular status in acute hemorrhage.
GI: Obstructive disease (e.g., achalasia, pyloroduodenal stenosis, or pyloric obstruction, cardiospasm, etc.); paralytic ileus; intestinal atony of the elderly or debilitated patient; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; hepatic disease.
GU: Obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy); renal disease.
Musculoskeletal: Myasthenia gravis.

Warnings ⮝

Heat prostration can occur with anticholinergic drug use (fever and heat stroke due to decreased sweating) in the presence of a high environmental temperature.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. Treatment of diarrhea with these drugs is inappropriate and possibly harmful.

Usage in the elderly: Elderly patients may react with excitement, agitation, drowsiness and other untoward manifestations to even small doses of anticholinergic drugs.

Usage in gastric ulcer may produce a delay in gastric emptying time and may complicate such therapy (antral stasis).

Precautions ⮝

General:

Potentially hazardous tasks: Atropine may produce drowsiness, dizziness or blurred vision; patients should observe caution while driving or performing other tasks requiring alertness.

Atropine should be used with caution in:
CNS: Autonomic neuropathy.
Ocular: Glaucoma, light irides. If there is mydriasis and photophobia, dark glasses should be worn. Atropine should be used with caution in patients over 40 years of age because of the increased incidence of glaucoma.
GI: Hepatic disease; early evidence of ileus, as in peritonitis; ulcerative colitis (large doses may suppress intestinal motility and precipitate or aggravate toxic megacolon); hiatal hernia associated with reflux esophagitis (anticholinergics may aggravate it).
GU: Renal disease; prostatic hypertrophy. Patients with prostatism can have dysuria may require catheterization.
Endocrine: Hyperthyroidism.
Cardiovascular: Coronary heart disease; congestive heart failure; cardiac arrhythmias; tachycardia; hypertension.
Usage in biliary tract disease: The use of atropine should not be relied upon in the presence of complication of biliary tract disease.
Special risk patients: Atropine should be used cautiously in infants, small children and persons with Down s syndrome, brain damage or spasticity.
Pulmonary: Debilitated patients with chronic lung disease; reduction in bronchial secretions can lead to inspissation and formation of bronchial plugs.

Atropine should be used cautiously in patients with asthma or allergies.

Drug Interactions:

Antihistamines, antipsychotics, antiparkinson drugs, alphaprodine, buclizine, meperidine, orphenadrine, benzodiazepines and tricyclic antidepressants may enhance the anticholinergic effects of atropine and its derivatives. Nitrates, nitrites, alkalinizing agents, primidone, thioxanthenes, methylphenidate, disopyramide, procainamide and quinidine may also potentiate side effects. Monoamine oxidase inhibitors block detoxification of atropine, and thus, potentiate its actions. Concurrent long-term therapy with corticosteroids or haloperidol may increase intraocular pressure. Atropine may antagonize the miotic actions of cholinesterase inhibitors.

The bronchial relaxation produced by sympathomimetics is enhanced by atropine.

Inhibition of gastric acid secretion by atropine is antagonized by guanethidine, histamine and reserpine.

Because of the potential for adverse effects, atropine should be used cautiously with digitalis, slow release digoxin tablets, cholinergics and neostigmine.

The I.V. administration of atropine in the presence of cyclopropane anesthesia can result in ventricular arrhythmias.

Atropine may enhance nitrofurantoin and thiazide-diuretic bioavailability by slowing GI motility.

The effects of metoclopramide on GI motility are antagonized by atropine.

Usage in Pregnancy:

Teratogenic Effect - Pregnancy Category B

Reproduction studies performed in mice at doses of 50 mg per kg of body weight have revealed no evidence of impaired fertility or harm to the fetus due to atropine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Usage in Lactation:

Atropine may be excreted in milk, causing infant toxicity, and may reduce breast milk production. Documentation is lacking or conflicting. Safety for use in nursing mothers has not been established.

Usage in Children:

(See DOSAGE AND ADMINISTRATION recommendations under Usual Pediatric Dosage ).

Adverse Reactions ⮝

GI: Xerostomia; altered taste perception; nausea; vomiting; dysphagia; heartburn, constipation; bloated feeling; paralytic ileus; gastroesophageal reflux.
GU: Urinary hesitancy and retention; impotence.
Ocular: Blurred vision; mydriasis; photophobia; cycloplegia; increased intraocular pressure.
Cardiovascular: Palpitations; bradycardia (following low doses of atropine); tachycardia (after higher doses).
CNS: Headache; flushing; nervousness; drowsiness; weakness; dizziness; insomnia; fever. Elderly patients may exhibit mental confusion or excitement to even small doses. Large doses may produce CNS stimulation (restlessness, tremor).
Dermatologic - Hypersensitivity: Severe allergic reactions including anaphylaxis, urticaria and other dermal
manifestations.
Other: Suppression of lactation; nasal congestion; decreased sweating. Complete anhidrosis cannot occur because large doses would be required, producing severe side effects from parasympathetic paralysis.

Overdosage ⮝

Symptoms:
GI: Dry mouth; dysphagia; vomiting; nausea; abdominal distention.
CNS: Theoretically, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and paralysis.
CNS stimulation; delirium; drowsiness; stupor; fever; dizziness; headache; restlessness; seizures; depression; tremor; hallucinations; ataxia; coma; psychotic behavior; other signs of an acute organic psychosis.
Cardiovascular: Circulatory failure; rapid pulse and respiration; tachycardia with weak pulse; hypertension; palpitations.
GU: Urinary urgency with difficulty in micturition.
Ocular: Blurred vision; photophobia; dilated pupils.
Miscellaneous: Leukocytosis, flushed hot dry skin, rash; respiratory failure.

Treatment:
Administer supportive and symptomatic therapy as indicated.
Physostigmine 1 to 3 mg I.V. has been utilized to reverse anticholinergic effects. However, profound bradycardia, asystole and seizures may occur. The role of physostigmine is not clear; its use should be avoided if other therapeutic agents are successful in reversing cardiac dysrhythmias. Neostigmine methylsulfate 0.5 to 2 mg I.V., repeated as needed, may be given. Diazepam or short-acting barbiturates may control excitement. Hemodialysis is ineffective for atropine poisoning. Hyperpyrexia may be treated with physical cooling measures. If photophobia occurs, the patient may be kept in a dark room.

Dosage & Administration ⮝

The usual dose of atropine sulfate is 0.4 to 0.6 mg. Suggested dosages for pediatric patients are as follows:
7 - 16 lbs. 0.1 mg 40 - 65 lbs. 0.3 mg
17 - 24 lbs. 0.15 mg 65 - 90 lbs. 0.4 mg
24 - 40 lbs. 0.2 mg Over 90 lbs. 0.4 to 0.6 mg

Table of Dosage Equivalents

These doses may be exceeded in certain cases.
For hypotonic radiography of the gastrointestinal tract, the usual adult dose is 1 mg intramuscularly.
Adults suspected of contact with organic phosporous insecticides of the parathion type should be given atropine sulfate 0.8 mg intramuscularly. If an atropine effect is not apparent within 30 minutes or if definite symptoms of the poisoning occur (nausea, vomiting, diarrhea, pupillary constriction, pulmonary edema, fasciculations of eyelids and tongue, jerky ocular movements and excessive sweating, salivation and bronchial secretion), atropine sulfate 2 mg should be given intramuscularly at hourly intervals until signs of atropinization are observed. Up to 2 or 3 times of this dose (4 to 6 mg) may be required in severe cases.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How Supplied ⮝

ATROPINE SULFATE INJECTION, USP.

In unit-use packages containing the Luer-Jet Luer-Lock Prefilled Syringe.

Stock No.	Size	NDC NO.
3339 1 mg (0.1 mg/mL)	10 mL	76329-3339-1 FOR I.V. USE

Ten cartons per package.

Syringe Assembly Directions:

USE ASEPTIC TECHNIQUE
Do not assemble until ready to use.

*CAUTION IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY.

Store at controlled room temperature 15 to 30 C (59 to 86 F).

Rx Only

INTERNATIONAL MEDICATION SYSTEMS, LIMITED
So. El Monte, CA 91733, U.S.A.
An Amphastar Pharmaceuticals Company Rev. 2-13
INTERNATIONAL MEDICATION SYSTEMS, LIMITED 2013

DRUG: Atropine Sulfate

GENERIC: Atropine Sulfate

DOSAGE: INJECTION

ADMINSTRATION: PARENTERAL

NDC: 70518-2054-0

PACKAGING: 10 mL in 1 SYRINGE

OUTER PACKAGING: 10 in 1 CARTON

ACTIVE INGREDIENT(S):

• Atropine Sulfate 0.1mg in 1mL

INACTIVE INGREDIENT(S):

ATROPINE SULFATE atropine sulfate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2054(NDC:76329-3339) Route of Administration PARENTERAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) ATROPINE SULFATE 0.1 mg in 1 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70518-2054-0 10 in 1 CARTON 05/01/2019 1 10 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/01/2019

Labeler - REMEDYREPACK INC. (829572556)

Revised: 5/2019 Document Id: 87da198d-b609-7e09-e053-2995a90a4499 34391-3 Set id: 12d5560c-cbd4-4173-90c9-9d25206f51cc Version: 1 Effective Time: 20190501 REMEDYREPACK INC.

Principal Display Panel, Vial ⮝

Atropine Sulfate Injection, USP
8 mg/20 mL (0.4 mg/mL)
20 mL Multiple Dose Vial
NDC 0641-6006-01

Principal Display Panel, Serialized Vial ⮝

ATROPINE SULFATE atropine sulfate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1311(NDC:0641-6006) Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) ATROPINE SULFATE 0.4 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg in 1 mL BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg in 1 mL WATER (UNII: 059QF0KO0R) SULFURIC ACID (UNII: O40UQP6WCF)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51662-1311-1 20 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 10/06/2018

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/06/2018

Labeler - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Registrant - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Establishment
Name	Address	ID/FEI	Business Operations
HF Acquisition Co LLC, DBA HealthFirst		045657305	relabel(51662-1311)

Revised: 10/2018 Document Id: 77935b57-fcf7-c88a-e053-2a91aa0a0a80 34391-3 Set id: 77935b57-fcf6-c88a-e053-2a91aa0a0a80 Version: 1 Effective Time: 20181006 HF Acquisition Co LLC, DBA HealthFirst