GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE- guaifenesin and dextromethorphan hydrobromide tablet 
Yichang Humanwell Pharmaceutical Co. Ltd.

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.

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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.

label for DM

9009

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62732-9009
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (White to off white) Score2 pieces
ShapeCAPSULESize18mm
FlavorImprint Code L3Z9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62732-9009-1200 in 1 BOTTLE; Type 0: Not a Combination Product03/03/201705/08/2017
2NDC:62732-9009-217000 in 1 BAG; Type 0: Not a Combination Product04/21/201705/08/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/03/201705/08/2017
Labeler - Yichang Humanwell Pharmaceutical Co. Ltd. (527225336)

Revised: 11/2021
 
Yichang Humanwell Pharmaceutical Co. Ltd.