GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE tablet

Guaifenesin and Dextromethorphan Hydrobromide by

Drug Labeling and Warnings

Guaifenesin and Dextromethorphan Hydrobromide by is a Otc medication manufactured, distributed, or labeled by Yichang Humanwell Pharmaceutical Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredient (per tablet): Purpose
• Dextromethorphan Hydrobromide 20mg: Cough Suppressant
• Guaifenesin 400mg: Expectorant

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

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)