PRIMATENE- ephedrine hydrochloride tablet

Primatene by

Drug Labeling and Warnings

Primatene by is a Otc medication manufactured, distributed, or labeled by Foundation Consumer Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each tablet)

Ephedrine HCl 12.5 mg

Purpose

Bronchodilator

Use

• for temporary relief of mild symptoms of intermittent asthma:
  • wheezing
  • tightness of chest
  • shortness of breath

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.
• if you have ever had an allergic reaction to this product or any of its ingredients

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

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)

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

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

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
• adults and children 12 years and over: take 1-2 tablets every 4 hours as needed. Do not take more than 12 tablets in 24 hours.
• children under 12 years of age: do not use

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

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

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Distributed by:
Foundation Consumer Brands, LLC
Pittsburgh, PA 15212

PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Blister Pack Carton

NEW FORMULA

Primatene®
TABLETS

Ephedrine HCl 12.5 mg Bronchodilator

For the Temporary Relief of Mild Symptoms of
INTERMITTENT ASTHMA

24 TABLETS

INGREDIENTS AND APPEARANCE

PRIMATENE 
ephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80070-600
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	YELLOW (Light yellow color)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	PT;in;circle;engraved
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80070-600-24	2 in 1 CARTON	01/22/2021
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 80070-600-60	5 in 1 CARTON	01/22/2021
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/22/2021

Labeler - Foundation Consumer Brands (117603632)