ACETAMINOPHEN 325 MG ,DEXTROMETHORPHAN HYDROBROMIDE 10 MG SOFT GELATIN CAPSULES (ORANGE)

Manufacturer
Softgel Healthcare Private Limited
Effective date
2026-08-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-05 06:00:19

Label at a glance#

ProductAcetominophen, Dextromethorphan hydrobromide
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN
Label structure15 sections

Indications and uses

temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat minor aches & pains headache fever

Dosage and administration

take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over : 2 softgels with water every 4 hrs children 4 to under 12 yrs : ask a doctor children under 4 yrs : do not use

Label contents#

Full prescribing information#

Active ingredients (in each softgelatin capsule)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 10 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/Fever reducer
Cough suppressant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • minor aches & pains
  • headache
  • fever

Warnings

WARNINGS SECTION

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

  • more than 8 softgels 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

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, & tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain or cough get worse or last 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.

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

  • take only as directed
  • do not exceed 8 softgels per 24 hrs
  • adults & children 12 yrs & over : 2 softgels with water every 4 hrs
  • children 4 to under 12 yrs : ask a doctor
  • children under 4 yrs : do not use

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no. 40, FD&C Yellow no.6, gelatin, glycerin, polyethylene glycol 400, povidone K-30, propylene glycol, purified water, sorbitol sorbitan solution

Other information

OTHER SAFETY INFORMATION

Store at 20-25 ºC (68-77ºF)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aceto-dextroaceto-dextro

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35916-221135916-2211-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-06-06daily-update2026-06-11 05:11:05

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
Acetominophen, Dextromethorphan hydrobromideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDESoftgel Healthcare Private Limited5302bc6d-d947-31c3-e063-6294a90a09f32026-08-03WarningsExact identifier
ndc (package): 35916-2211-1
ndc (product): 35916-2211
ndc11 (package): 35916221101
spl id: 5821ad21-a279-cbd8-e063-6394a90ada5f
spl set id: 5302bc6d-d947-31c3-e063-6294a90a09f3

Reported adverse events (FAERS/openFDA)#

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