Acetaminophen 325 mg, Dextromethorphan HBr 10mg, Guaifenesin 200 mg Capsules (Day Severe)

Manufacturer
Softgel Healthcare Pvt Ltd
Effective date
2026-04-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:55:04

Label at a glance#

ProductAcetaminophen, Dextromethorphan HBr ,Guaifenesin
Active ingredientGUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure15 sections

Indications and uses

temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passage ways of bothersome mucus and make coughs more productive.

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients (in each Softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 10 mg

Guaifenesin USP 200 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passage ways of bothersome mucus and make coughs more productive.

Warnings

WARNINGS SECTION

Liver warning:

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

  • more than 8 softgels in 24 hrs, 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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • 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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • pain, 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 years & over2 softgels with water every 4 hours
children 4 to under 12 yearsask a doctor
children under 4 yearsdo not use

Other information

OTHER SAFETY INFORMATION

  • store at no greater than 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no.1, FD&C red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution

bulk-label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2377385acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral CapsulePSN5
2377385acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral CapsuleSCD5
2377385acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG Oral CapsuleSY5
2377385APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral CapsuleSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35916-0184-2Acetaminophen, Dextromethorphan HBr ,Guaifenesin3000 in 1 POUCHCAPSULE, LIQUID FILLED30005
35916-0184-3Acetaminophen, Dextromethorphan HBr ,Guaifenesin2000 in 1 POUCHCAPSULE, LIQUID FILLED20005
35916-0184-3Acetaminophen, Dextromethorphan HBr ,Guaifenesin2 in 1 BOXCAPSULE, LIQUID FILLED25
35916-0184-4Acetaminophen, Dextromethorphan HBr ,Guaifenesin1500 in 1 BAGCAPSULE, LIQUID FILLED15005
35916-0184-4Acetaminophen, Dextromethorphan HBr ,Guaifenesin2 in 1 BOXCAPSULE, LIQUID FILLED25

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35916-018435916-0184-2, 35916-0184-3, 35916-0184-4

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
42026-01-20monthly-update2026-06-03 17:53:02
32025-12-12monthly-update2026-06-03 17:45:53

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
Acetaminophen, Dextromethorphan HBr ,GuaifenesinACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESINSoftgel Healthcare Pvt Ltd353ef34f-760d-ae92-e063-6294a90a5b4a2026-04-27WarningsExact identifier
ndc (package): 35916-0184-3
ndc (package): 35916-0184-2
ndc (package): 35916-0184-4
ndc (product): 35916-0184
ndc11 (package): 35916018403
ndc11 (package): 35916018402
ndc11 (package): 35916018404
spl id: 50039825-a8a4-cd65-e063-6294a90a5fd6
spl set id: 353ef34f-760d-ae92-e063-6294a90a5b4a

Reported adverse events (FAERS/openFDA)#

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