ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR- acetaminophen, guaifenesin, phenylephrine hcl and dextromethorphan hbr capsule, liquid filled 
Softgel Healthcare Pvt Ltd

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Acetaminophen 325mg, Guaifenesin 200mg, Phenylephrine Hydrochloride 5mg and Dextromethorphan Hydrobromide 10mg softgelatin Capsules


Active ingredients (in each Softgel)

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 10 mg

Guaifenesin USP 200 mg

Phenylephrine HCl USP 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant


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 red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution

MAX STRENGTH

NDC 35916-0166-1

Compared to the active ingredient in Vicks® DayQuil ™ severe COLD & FLU LiquiCaps™

Acetaminophen 325mg, Guaifenesin 200mg, Phenylephrine HCl 5mg And Dextromethorphan HBr 10mg Softgelatin Capsules

Headache, Fever, Sore throat, Minor aches & Pains

Chest congestion, Thins & loosen mucus

Nasal congestion, Sinus Pressure

cough

24 Softgels

Day Time Severe Cold & Flu

(Non-Drowsy)

Day time Severe

ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR 
acetaminophen, guaifenesin, phenylephrine hcl and dextromethorphan hbr capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0166
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
POVIDONE (UNII: FZ989GH94E)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
Product Characteristics
Colororange (Transparent) Scoreno score
ShapeCAPSULE (oblong square) Size21mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35916-0166-12 in 1 CARTON10/29/2024
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/29/2024
Labeler - Softgel Healthcare Pvt Ltd (675584180)

Revised: 10/2024
Document Id: 24bc9ae6-8e90-c0a0-e063-6394a90a407f
Set id: 24bc9ae6-8e8f-c0a0-e063-6394a90a407f
Version: 1
Effective Time: 20241029
 
Softgel Healthcare Pvt Ltd