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

Acetaminophen, Dextromethorphan HBr and Phenyephrine HCl by

Drug Labeling and Warnings

Acetaminophen, Dextromethorphan HBr and Phenyephrine HCl by is a Otc medication manufactured, distributed, or labeled by SOFTGEL HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYEPHRINE HCL- acetaminophen, dextromethorphan hbr and phenyephrine hcl capsule, liquid filled 
SOFTGEL HEALTHCARE PRIVATE LIMITED

----------

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

Active Ingredients (In each capsules)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 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

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

minis-ultra-day

ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYEPHRINE HCL 
acetaminophen, dextromethorphan hbr and phenyephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 35916-0187
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
POVIDONE K30 (UNII: U725QWY32X)  
SORBITOL (UNII: 506T60A25R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
GELATIN (UNII: 2G86QN327L)  
Product Characteristics
Colororange (Glittering) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code 32
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 35916-0187-11000 in 1 BAG; Type 0: Not a Combination Product03/03/202503/06/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/03/202503/06/2025
Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (675584180)

Revised: 3/2025