GUAIFENESIN,DEXTROMETHORPHAN HBR capsule, liquid filled

Guaifenesin,Dextromethorphan Hbr by

Drug Labeling and Warnings

Guaifenesin,Dextromethorphan Hbr by is a Otc medication manufactured, distributed, or labeled by Softgel Healthcare Pvt Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each soft gelatin capsule)

Guaifenesin USP 400mg

Dextromethorphan HBr USP 20mg

PURPOSE

Purposes

Expectorant

Cough suppressant

INDICATIONS & USAGE

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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

• cough accompained by excessive phlegm(mucus)
• persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema

When using this product

• do not exceed recommended dosage
• do not use for more than 7 days

STOP USE

Stop use and ask a doctor if

• cough lasts for more than 7 days,recurs, or is accompanied by fever, rash, or persistent headache .

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 accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• do not exceed 6 doses in 24 hours
• take with a full glass of water
• adults and children 12 years of age and over: take 1 softgel every 4 hours
• children under 12 years of age: do not use

OTHER SAFETY INFORMATION

Other information

• store at 25°C (77°F); excursions permitted between 15° -30°C (59° -86°F)
• Keep in dry place and do not expose to heat

INACTIVE INGREDIENT

Inactive ingredients

gelatin, glycerin, polyethylene glycol 400, povidone k-30,propylene glycol, purified water, sorbitol sorbitan solution

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35916-0759
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GELATIN (UNII: 2G86QN327L)
POVIDONE K30 (UNII: U725QWY32X)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	yellow (Clear transparent)	Score	no score
Shape	CAPSULE (Oblong)	Size	22mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35916-0759-3	2 in 1 BOX	09/15/2025
1		2000 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 35916-0759-4	2 in 1 BOX	01/13/2026
2		1500 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/11/2025

Labeler - Softgel Healthcare Pvt Ltd (676666501)