ACETAMINOPHEN 325MG, DEXTROMETHORPHAN HBR 10MG AND PHENYLEPRINE HCL 5MG- acetaminophen, dextromethorphan hbr and phenylephrine hcl capsule, liquid filled 
Softgel Healthcare Private Limited

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Acetaminophen 325mg, Dextromethorphan Hydrobromide 10mg, Phenylephrine Hydrochloride 5mg Capsules (Minis, Ultra-concentrated, Orange)

Active ingredients (in each softgelatin capsule)

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 10 mg

Phenylephrine HCl USP 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

• temporarily relieves these symptoms due to a cold or flu:
• minor aches and pains • headache • cough
•sore throat • nasal and sinus congestion
•temporarily reduces fever

Warnings

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

• more than 4,000 mg of acetaminophen in 24 hours

• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

• skin reddening • blisters • rash • hives
• facial swelling • asthma (wheezing) • shock

If a skin or general allergic 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

● with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

● 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.

● if you have ever had an allergic reaction to this product or any of its ingredients

● in children under 12 years of age

Ask a doctor before use if you have

● liver disease ● heart disease ● high blood pressure

● thyroid disease ● diabetes

● cough with excessive phlegm (mucus)

● difficulty in urination due to enlargement of the prostate gland

● persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product do not exceed recommended dosage

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

Other information

● store at room temperature. Avoid excessive heat above 40ºC (104ºF).

Inactive ingredients

FD&C yellow no.5, FD&C yellow no.6, gelatin, glycerin, mica, polyethylene glycol 400, povidone K 30, purified water, sorbitol sorbitan solution, titanium dioxide

BULK PACKAGE LABEL

bulk labelMinis-ultra-day-orange

ACETAMINOPHEN 325MG, DEXTROMETHORPHAN HBR 10MG AND PHENYLEPRINE HCL 5MG 
acetaminophen, dextromethorphan hbr and phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0188
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
MICA (UNII: V8A1AW0880)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POVIDONE K30 (UNII: U725QWY32X)  
GELATIN (UNII: 2G86QN327L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
Colororange (Glitter) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35916-0188-11000 in 1 BAG; Type 0: Not a Combination Product03/21/2025
2NDC:35916-0188-22 in 1 BOX06/12/2025
23000 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/21/2025
Labeler - Softgel Healthcare Private Limited (675584180)

Revised: 6/2025
Document Id: 371c52b5-2bc8-ad77-e063-6394a90a8e38
Set id: 30ab39f3-27cc-5728-e063-6394a90a9cbe
Version: 2
Effective Time: 20250608
 
Softgel Healthcare Private Limited