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

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

Drug Labeling and Warnings

Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME) by is a Otc medication manufactured, distributed, or labeled by Health Pharma USA LLC, OCEAN HEALTHCARE PVT. LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• nasal congestion
• cough due to minor throat and bronchial irritation
• headache
• minor aches and pains
• fever
• sore throat

Warnings

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

• more than 4 doses in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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

• skin reddening
• blisters
• rash

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

• with any other drug containing acetaminophen (prescription or non-prescription).
• 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

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma or emphysema

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

• you get nervous, dizzy or sleepless
• pain, nasal congestion or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

SPL UNCLASSIFIED SECTION

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

• take only as directed
• do not exceed 4 doses per 24 hours

• adults and children 12 years and over: take 2 softgels with water every 4 hours
• children 4 to under 12 years: ask a doctor
• children under 4 years: do not use

Other information

• store at room temperature.
• DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

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

INGREDIENTS AND APPEARANCE

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71679-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score	no score
Shape	CAPSULE (Oblong)	Size	21mm
Flavor		Imprint Code	CF01
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71679-101-00	3000 in 1 DRUM; Type 0: Not a Combination Product	09/24/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/24/2025

Labeler - Health Pharma USA LLC (080804485)

Registrant - Health Pharma USA LLC (080804485)

Establishment
Name	Address	ID/FEI	Business Operations
OCEAN HEALTHCARE PVT. LTD.		873673519	manufacture(71679-101)