DEXTROMETHORPHAN HBR,GUAIFENESIN- dextromethorphan hbr,guaifenesin capsule, liquid filled 
SOFTGEL HEALTHCARE PRIVATE LIMITED

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Dextromethorphan Hydrobromide 10 mg and Guaifenesin 200 mg Softgelatin Capsules

Active ingredient (in each soft gelatin capsule)

Dextromethorphan HBr USP 10mg

Guaifenesin USP 200mg

Purposes

Cough suppresent

Expectorant

Uses

Warnings

Do not use

Ask a doctor before use if you have

When using this product do not use more than directed

Stop use and ask a doctor if

These could be signs 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 right away.

Directions

Other information

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

bulk label

DEXTROMETHORPHAN HBR,GUAIFENESIN 
dextromethorphan hbr,guaifenesin capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0760
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorgreen (Opaque) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35916-0760-11000 in 1 BAG; Type 0: Not a Combination Product03/21/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/21/2025
Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (676666501)

Revised: 1/2026
Document Id: 47b53021-eb30-c736-e063-6294a90ae369
Set id: 2fbbfc7c-81a9-b647-e063-6394a90a55ac
Version: 2
Effective Time: 20260127
 
SOFTGEL HEALTHCARE PRIVATE LIMITED