Label: DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE liquid
- NDC Code(s): 69367-184-08
- Packager: Westminster Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated March 14, 2018
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold
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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 an 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
- a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
- a cough that occurs with too much phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
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Directions
- do not take more than 6 doses in any 24-hour period
- use enclosed dosage cup or tablespoon (TBSP)
- dose as follows or as directed by a doctor
Adults and children 12 years of age and over: 15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) in a 24 hour period Children 6 to under 12 years of age: 7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) in a 24 hour period. Children under 6 years of age: Consult a doctor. - Other information
- Inactive ingredients
- Questions or Comments?
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PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label
NDC 69367-184-08
Cough
Cold/CongestionDextromethorphan HBr
Guaifenesin
Phenylephrine HClEach 15 mL (TBSP) contains:
Dextromethorphan HBr
18 mg
Guaifenesin
200 mg
Phenylephrine HCl
10 mgCough Suppressant ∙ Expectorant ∙ Nasal Decongestant
Raspberry Flavor
Alcohol Free / Sugar Free
Gluten Free / Dye Free8 fl. oz. (240 mL)
Westminster
Pharmaceuticals -
INGREDIENTS AND APPEARANCE
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69367-184 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 18 mg in 15 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) Product Characteristics Color Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69367-184-08 240 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/15/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M012 03/15/2018 Labeler - Westminster Pharmaceuticals, LLC (079516651)