Acetaminophen, Dextromethorphan HBr and Phenyephrine HCl

Manufacturer
SOFTGEL HEALTHCARE PRIVATE LIMITED
Effective date
2025-03-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:40:53

Label at a glance#

ProductAcetaminophen, Dextromethorphan HBr and Phenyephrine HCl
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure15 sections

Indications and 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

Dosage and administration

• 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

Label contents#

Full prescribing information#

Active Ingredients (In each capsules)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

• 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

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

minis-ultra-dayminis-ultra-day

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35916-018735916-0187-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2faa56ce-2823-713c-e063-6394a90abdc22ef584ba-018b-793d-e063-6394a90a2af02025-03-06WarningsExact identifier
spl set id: 2ef584ba-018b-793d-e063-6394a90a2af0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.