DEXTROMETHORPHAN HBR,GUAIFENESIN capsule, liquid filled

Dextromethorphan Hbr,Guaifenesin by

Drug Labeling and Warnings

Dextromethorphan Hbr,Guaifenesin by is a Otc medication manufactured, distributed, or labeled by SOFTGEL HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each soft gelatin capsule)

Dextromethorphan HBr USP 10mg

Guaifenesin USP 200mg

PURPOSE

Purposes

Cough suppresent

Expectorant

INDICATIONS & USAGE

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

WARNINGS

Warnings

DO NOT USE

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 DOCTOR

Ask a doctor before use if you have

• persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis, or emphysema
• cough that occurs with too much phlegm(mucus)

WHEN USING

When using this product do not use more than directed

STOP USE

Stop use and ask a doctor if

• cough lasts more than 7 days,comes back,or occur with fever, rash, or headache that lasts.

These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of overdose, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION

Directions

• do not take more than 12 liquid gels in any 24-hour period
• adults and children 12 years of age and over: take 2 liquid gels every 4 hours
• children under 12 years of age: do not use

OTHER SAFETY INFORMATION

Other information

• store at 20-25°C (68-77°F)
• avoid excessive heat

INACTIVE INGREDIENT

Inactive ingredients

D&C yellow 10, FD&C blue 1, gelatin, glycerin, polyethylene glycol 400, povidone k-30, purified water, sorbitol sorbitan solution, titanium dioxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DEXTROMETHORPHAN HBR,GUAIFENESIN 
dextromethorphan hbr,guaifenesin capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35916-0760
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GELATIN (UNII: 2G86QN327L)
POVIDONE K30 (UNII: U725QWY32X)

Product Characteristics
Color	green (Opaque)	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35916-0760-1	1000 in 1 BAG; Type 0: Not a Combination Product	03/21/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/21/2025

Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (676666501)