NDC | 0363-2529-67 |
Set ID | 10816e9d-0c53-424b-b482-fdd01a4d8525 |
Category | HUMAN OTC DRUG LABEL |
Packager | Walgreens Company |
Generic Name | |
Product Class | alpha-Adrenergic Agonist, beta-Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS AND USAGE
- WARNINGS
-
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
-
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
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE AND ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
-
SPL UNCLASSIFIED SECTION
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®
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BRONCHIAL ASTHMA RELIEF
ephedrine hcl, guaifenesin tabletProduct 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)