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

Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg by

Drug Labeling and Warnings

Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg by is a Otc medication manufactured, distributed, or labeled by Softgel Healthcare Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

• pain, cough, or nasal congestion 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.

• nervousness, dizziness, or sleeplessness occurs

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

• do not take more than the recommended dose
• adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
• children under 12 years: do not use

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35916-0188
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
WATER (UNII: 059QF0KO0R)
MICA (UNII: V8A1AW0880)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GELATIN (UNII: 2G86QN327L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
POVIDONE K30 (UNII: U725QWY32X)

Product Characteristics
Color	orange (Glitter)	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35916-0188-1	1000 in 1 BAG; Type 0: Not a Combination Product	03/21/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/21/2025

Labeler - Softgel Healthcare Private Limited (675584180)