Label: PRIMATENE- ephedrine hydrochloride tablet
- NDC Code(s): 80070-600-24, 80070-600-60
- Packager: Foundation Consumer Brands
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated January 25, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
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
- thyroid disease
- 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
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Blister Pack Carton
INGREDIENTS AND APPEARANCE
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)