ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HYDROBROMIDE 10 MG, PHENLYEPHRINE HYDROCHLORIDE 5 MG SOFTGEL (DAY-TIME)- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled 
Health Pharma USA LLC

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Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)

Active ingredients (in each softgels)

Acetaminophen, USP 325 mg

Dextromethorphan Hydrobromide, USP 10 mg

Phenlyephrine Hydrochloride, USP 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

Temporarily relieves common cold and 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 aretaking the blood thinning drug warfarin

When using this product,do not use more than directed.

Stop use and ask a doctor if

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 (1-800-222-122) right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

Direction

adults and children 12 years and overtake 2 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 #40, FD&C yellow #6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Purified Water, Sorbitol Sorbitan Solution.

Questions?

call toll-free 1-844-832-1138

PRINCIPAL DISPLAY PANEL

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ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HYDROBROMIDE 10 MG, PHENLYEPHRINE HYDROCHLORIDE 5 MG SOFTGEL (DAY-TIME) 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71679-101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorredScoreno score
ShapeCAPSULE (Oblong) Size21mm
FlavorImprint Code CF01
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71679-101-003000 in 1 DRUM; Type 0: Not a Combination Product09/24/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/24/2025
Labeler - Health Pharma USA LLC (080804485)
Registrant - Health Pharma USA LLC (080804485)
Establishment
NameAddressID/FEIBusiness Operations
OCEAN HEALTHCARE PVT. LTD.873673519manufacture(71679-101)

Revised: 9/2025
Document Id: 3f86a539-828a-a6d3-e063-6294a90ab8c2
Set id: a03befb4-d86d-43e4-8097-eda5c8bb25be
Version: 1
Effective Time: 20250924
 
Health Pharma USA LLC