PRIMATENE: Package Insert and Label Information

PRIMATENE- ephedrine hydrochloride and guaifenesin tablet
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENTS (IN EACH TABLET)

Ephedrine HCl, USP 12.5 mg

Guaifenesin, USP 200 mg

PURPOSES

Bronchodilator

Expectorant

USES

for temporary 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 to 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 more than 12 tablets in 24 hours
use more than 8 tablets in 24 hours for 3 or more days a week
have more than 2 asthma attacks in a week

These may be signs that your asthma is getting worse

This product will not give you asthma relief as quickly as an inhaled bronchodilator

Do not use

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

Ask a 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 an enlarged 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 a doctor or 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 a rapid heart beat
you have tremors, nervousness, or seizure
cough lasts more than 7 days, comes back, or is accompanied by 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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

do not take more than directed
age dose

adults and children 12 years of age and over

oral dose is 1-2 tablets (12.5 to 25 mg) every 4 hours as needed. Do not take more than 12 tablets (150 mg) in 24 hours

children under 12 years of age

ask a doctor

OTHER INFORMATION

store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

colloidal silicon dioxide, crospovidone, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone

QUESTIONS OR COMMENTS?

Call weekdays from 9 AM to 5 PM EST at 1-800-535-0026

For most recent product information, visit www.PrimateneTablets.com

PRINCIPAL DISPLAY PANEL

NDC 0573-2952-20

Primatene®
TABLETS

Ephedrine HCl, Bronchodilator/Guaifenesin, Expectorant
Helps Loosen Phlegm (Mucus)

For the Temporary Relief of Mild Symptoms of
INTERMITTENT ASTHMA

60 TABLETS

Principal Display Panel -- 60 Tablet Carton
(click image for full-size original)
PRIMATENE
ephedrine hcl, guaifenesin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-2952
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPHEDRINE HYDROCHLORIDE (EPHEDRINE) EPHEDRINE HYDROCHLORIDE 12.5 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color YELLOW (Light yellow color) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code P;in;circle;engraved;bisect
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0573-2952-10 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 12 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0573-2952-10)
2 NDC:0573-2952-20 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 12 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0573-2952-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/06/2004 06/30/2023
Labeler — GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
Name Address ID/FEI Operations
Wyeth Pharmaceuticals Company 829390975 ANALYSIS (0573-2952), LABEL (0573-2952), MANUFACTURE (0573-2952), PACK (0573-2952)

Revised: 06/2021 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.