ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN- acetaminophen, dextromethorphan hbr ,guaifenesin capsule, liquid filled 
Softgel Healthcare Pvt Ltd

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Acetaminophen 325 mg, Dextromethorphan HBr 10mg, Guaifenesin 200 mg Capsules (Day Severe)


Active ingredients (in each Softgel)

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 10 mg

Guaifenesin USP 200 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant


Uses

temporarily relieves common cold/flu symptoms:

Warnings

Liver warning:

This product contains acetaminophen.Severe liver damage may occur if you take

Allergy Alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away

Sore throat warning:

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

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.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

adults & children 12 years & over2 softgels with water every 4 hours
children 4 to under 12 yearsask a doctor
children under 4 yearsdo not use

Other information

Inactive ingredients

FD&C blue no.1, FD&C red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution

bulk-label

label

ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN 
acetaminophen, dextromethorphan hbr ,guaifenesin capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0184
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
POVIDONE K30 (UNII: U725QWY32X)  
Product Characteristics
Colorpink (Transparent) Scoreno score
ShapeCAPSULE (Oblong) Size22mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35916-0184-23000 in 1 POUCH; Type 0: Not a Combination Product05/17/2025
2NDC:35916-0184-32 in 1 BOX09/25/2025
22000 in 1 POUCH; Type 0: Not a Combination Product
3NDC:35916-0184-42 in 1 BOX01/16/2026
31500 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01205/17/2025
Labeler - Softgel Healthcare Pvt Ltd (676666501)

Revised: 4/2026
Document Id: 50039825-a8a4-cd65-e063-6294a90a5fd6
Set id: 353ef34f-760d-ae92-e063-6294a90a5b4a
Version: 5
Effective Time: 20260427
 
Softgel Healthcare Pvt Ltd