NDC | 0573-2952-10, 0573-2952-20 |
Set ID | 9005482c-25ae-d365-33d1-29269532c74d |
Category | HUMAN OTC DRUG LABEL |
Packager | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
Generic Name | |
Product Class | alpha-Adrenergic Agonist, beta-Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENTS (IN EACH TABLET)
- PURPOSES
- USES
-
WARNINGS
Asthma alert
Because asthma may be life threatening, see a doctor if you
- •
- are not better in 60 minutes
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- get worse
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- need more than 12 tablets in 24 hours
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- use more than 8 tablets in 24 hours for 3 or more days a week
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- 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
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- unless a doctor said you have asthma
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- 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
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- ever been hospitalized for asthma
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- heart disease
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- high blood pressure
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- diabetes
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- thyroid disease
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- seizures
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- narrow angle glaucoma
- •
- a psychiatric or emotional condition
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- trouble urinating due to an enlarged prostate gland
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- cough that occurs with too much phlegm (mucus)
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- 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
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- 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
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- your asthma is getting worse (see Asthma alert)
- •
- you have difficulty sleeping
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- you have a rapid heart beat
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- 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:
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- 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
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PRIMATENE
ephedrine hcl, guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-2952 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) 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 Marketing Start Date Marketing End Date 1 NDC:0573-2952-10 2 in 1 CARTON 01/06/2004 06/30/2023 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0573-2952-20 5 in 1 CARTON 01/06/2004 06/30/2023 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 01/06/2004 06/30/2023 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) Establishment Name Address ID/FEI Business Operations Wyeth Pharmaceuticals Company 829390975 ANALYSIS(0573-2952) , LABEL(0573-2952) , MANUFACTURE(0573-2952) , PACK(0573-2952)