BRONCHIAL ASTHMA RELIEF- ephedrine hcl, guaifenesin tablet

1. No Title 1572546534
2. No Title 1572457577
3. Active Ingredient
4. Purpose
5. Indications And Usage
6. Warnings
7. Do Not Use
8. Ask Doctor
9. Ask Doctor/pharmacist
10. Stop Use
11. When Using
12. Pregnancy Or Breast Feeding
13. Keep Out Of Reach Of Children
14. Dosage And Administration
15. Inactive Ingredient
16. Package Label.principal Display Panel

No Title 1572546534 ⮝

REV 05/12

Intentional abuse of this product can be harmful or fatal

Distribution of this product requires a DEA License

Tamper evident: Do Not USE IF CARTON HAS BEEN OPENED OR BLISTER UNITS ARE TORN OR BROKEN

GLUTEN FREE

Walgreens Pharmacist Survey Study, November 2010

#This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Primatene

No Title 1572457577 ⮝

Drug Facts

Active Ingredient  ⮝

(in each tablet)

Ephedrine HCl, USP 12.5 mg

Guaifenesin, USP 200 mg

Purpose  ⮝

Bronchodilator

Expectorant

Indications And Usage  ⮝

• for temporarily relief of mild symptoms of intermittent asthma:
• wheezing
• tightness of chest
• shortness of breath
• helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, and make coughs more productive

Warnings  ⮝

Asthma alert: Because asthma may be life threatening, see a doctor if you

• are not better in 60 minutes
• get worse
• need 12 tablets in any day
• use more than 8 tablets a day for more than 3 days a week
• have more than 2 asthma attacks a week

These may be signs that your asthma is getting worse

Do Not Use  ⮝

• unless a doctor said you have asthma
• if you are now taking prescription monoamine oxidase inhibitor (MAIO) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson s disease), or for 2 weeks after stopping the MAIO drug. If you do not know if your prescription drug contains an MAIO, ask a doctor or pharmacist before taking this product.

Ask Doctor  ⮝

before use if you have:

• ever been hospitalized for asthma
• heart disease
• high blood pressure
• diabetes
• thyroid disease
• seizures
• narrow angle glaucoma
• a psychiatric or emotional condition
• trouble urinating due to enlargement of the prostate gland
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask Doctor/pharmacist  ⮝

before use if you are

• taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions
• taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)

Stop Use  ⮝

and ask a doctor if

• your asthma is getting worse (see Asthma alert)
• you have difficulty sleeping
• you have rapid heartbeat
• you have tremors, nervousness, or seizure
• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache, these could be signs of a serious condition.

When Using  ⮝

this product

• your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.
• your risk of heart attack or stroke increases if you:
• have a history of high blood pressure or heart disease
• take this product more frequently or take more than the recommended dose
• avoid foods or beverages that contain caffeine
• avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect

Pregnancy Or Breast Feeding  ⮝

ask a health professional before use.

Keep Out Of Reach Of Children  ⮝

In case of overdose, get medical help or contact Poison Control Center right away.

Dosage And Administration  ⮝

• do not exceed dosage
• this adult product is not intended for use in children under 12 years of age

adults and children 12 years of age and over	take 1-2 tablets every 4 hours as needed, not to exceed 12 tablets in 24 hours
children under 12 years of age	ask a doctor

Inactive Ingredient  ⮝

D&C Yellow #10 Lake, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silica and Stearic Acid

Package Label.principal Display Panel  ⮝

WALGREENS PHARMACIST RECOMMENDED

Ephedrine HCl, USP 12.5 mg/ Bronchodilator
Guaifenesin, USP 200 mg/ Expectorant

• Helps breathing without drowsiness
• Restores free breathing
• Loosens phlegm

Compare to Primatene
active ingredients#

MAXIMUM SALE: ONE PACKAGE PER CUSTOMER

NOT FOR SALE TO MINORS

BRONCHIAL ASTHMA RELIEF ephedrine hcl, guaifenesin tablet

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-2529 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE 12.5 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics Color YELLOW (pale yellow) Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code CPC;2529 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-2529-67 4 in 1 CARTON 1 15 in 1 BLISTER PACK

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/13/2002

Labeler - Walgreens Company (008965063)

Registrant - Contract Pharmacal Corp (968334974)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corp		968334974	MANUFACTURE(0363-2529)

Revised: 9/2012 Document Id: 74ac83c5-db2e-485f-8fe4-0c29f94e1006 34390-5 Set id: 10816e9d-0c53-424b-b482-fdd01a4d8525 Version: 3 Effective Time: 20120917 Walgreens Company