NDC | 53807-530-04, 53807-530-08 |
Set ID | ec652577-df54-41fb-a9ee-bdc0f2e17d07 |
Category | HUMAN OTC DRUG LABEL |
Packager | Rij Pharmaceutical Corporation |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active Ingredients (in each 5mL tsp)
- PURPOSES
-
USES
- temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- temporarily restores freer breathing through the nose
-
WARNINGS
Do not use
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs 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 MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
When using this product
- do not use more than directed
- may cause marked drowsiness
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
- DIRECTIONS
- Other Information
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BROM TAPP DM
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53807-530 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 1 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53807-530-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/16/1999 2 NDC:53807-530-08 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/16/1999 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 03/16/1999 Labeler - Rij Pharmaceutical Corporation (144679156) Establishment Name Address ID/FEI Business Operations Rij Pharmaceutical Corporation 144679156 manufacture(53807-530)