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Guaifenesin and Dextromethorphan Hydrobromide

Medically reviewed on April 21, 2017

Dosage form: tablet
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 20mg, GUAIFENESIN 400mg
Labeler: Yichang Humanwell Pharmaceutical Co. Ltd.
NDC Code: 62732-9009

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.

Guaifenesin and Dextromethorphan HBr Tablets, 400 mg/20 mg

Active ingredient (per tablet) Purpose
Dextromethorphan Hydrobromide 20mgCough Suppressant
Guaifenesin 400mgExpectorant

Uses

■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.

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 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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

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 doctor

Other information

■ store at USP controlled room remperature

■ protect from heat, humidity, and light

Inactive ingredientscolloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62732-9009
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
POVIDONE K29/32 
SILICON DIOXIDE 
LACTOSE MONOHYDRATE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
MAGNESIUM STEARATE 
Product Characteristics
Colorwhite (White to off white) Score2 pieces
ShapeCAPSULESize18mm
FlavorImprint CodeL3Z9
Contains    
Packaging
#Item CodePackage Description
1NDC:62732-9009-1200 TABLET in 1 BOTTLE
2NDC:62732-9009-217000 TABLET in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/03/2017
Labeler - Yichang Humanwell Pharmaceutical Co. Ltd. (527225336)

 
Yichang Humanwell Pharmaceutical Co. Ltd.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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