Label: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE- guaifenesin and dextromethorphan hydrobromide tablet
- NDC Code(s): 62732-9009-1, 62732-9009-2
- Packager: Yichang Humanwell Pharmaceutical Co. Ltd.
- 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 April 21, 2017
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- ACTIVE INGREDIENT
Active ingredient (per tablet) Purpose Dextromethorphan Hydrobromide 20mg Cough Suppressant Guaifenesin 400mg Expectorant
■Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
■Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
■Helps make coughs more productive.Close
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 a MAOI, ask a doctor or pharmacist before using this product.
Ask a doctor before use if you have
■ persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema
■ cough that is accompanied by excessive phlegm (mucus)
Stop use and ask a doctor if
■ symptoms are accompanied by fever, rash, or persistent headache
■ cough persists for more than 1 week or tends to recur.
A persistent cough may be a sign of a serious condition.
■ Adults and children 12 years and over: take 1 tablet every 4 hours as needed
■ Children 6 to under 12 years: take 1/2 tablet every 4 hours as needed
■ Children under 6 years: consult a doctor
Do not exceed 6 doses in a 24 hour period or as directed by a doctorClose
- Other information
■ store at USP controlled room remperature
■ protect from heat, humidity, and lightClose
- INACTIVE INGREDIENT
Inactive ingredientscolloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.Close
- INGREDIENTS AND APPEARANCE
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
guaifenesin and dextromethorphan hydrobromide tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62732-9009 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE K29/32 (UNII: 390RMW2PEQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white (White to off white) Score 2 pieces Shape CAPSULE Size 18mm Flavor Imprint Code L3Z9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62732-9009-1 200 in 1 BOTTLE; Type 0: Not a Combination Product 03/03/2017 2 NDC:62732-9009-2 17000 in 1 BAG; Type 0: Not a Combination Product 04/21/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/03/2017 Labeler - Yichang Humanwell Pharmaceutical Co. Ltd. (527225336)