FDA.reportPublic FDA data

Theraflu Flu Relief Max Strength Daytime - Haleon US Holdings LLC

Manufacturer
Haleon US Holdings LLC
Effective date
2026-03-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:51:38

Label at a glance#

ProductTheraflu Flu Relief Max Strength Daytime Nighttime Value Pack
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE
Label structure18 sections

Indications and uses

temporarily relieves these symptoms due to a common cold: headache minor aches and pains cough due to minor throat and bronchial irritation minor sore throat pain temporarily reduces fever

Dosage and administration

do not use more than directed measure the dose correctly using the enclosed dosing cup adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 30 mL children under 12 years of age do not...

Label contents#

Full prescribing information#

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 1000 mg

Dextromethorphan HBr 30 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a common cold:
    • headache
    • minor aches and pains
    • cough due to minor throat and bronchial irritation
    • minor sore throat pain
  • 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 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

  • in a child under 12 years of age
  • if you are allergic to acetaminophen
  • 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
  • a breathing problem such as emphysema or chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic 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

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain or cough 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.

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. Prompt 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 use more than directed
  • measure the dose correctly using the enclosed dosing cup
  • adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist
  • do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor
  • children under 12 years of age: do not use
  1. Age
  1. Dose
  1. adults and children 12 years of age and over
  1. 30 mL
  1. children under 12 years of age
  1. do not use

Other information

SPL UNCLASSIFIED SECTION

  • each 30 mL contains: potassium 6 mg, sodium 32 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, light amber honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-328-5259

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 1000 mg

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Antihistamine

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a common cold:
    • headache
    • minor aches and pains
    • cough due to minor throat and bronchial irritation
    • minor sore throat pain
    • runny nose
  • 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 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

  • in a child under 12 years of age
  • if you are allergic to acetaminophen
  • 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 a MAO, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic 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
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

    • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain or cough 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.

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. Prompt 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 use more than directed
  • measure the dose correctly using the enclosed dosing cup
  • adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist
  • do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor
  • children under 12 years of age: do not use
  1. Age
  1. Dose
  1. adults and children 12 years of age and over
  1. 30 mL
  1. children under 12 years of age
  1. Do not use

Other information

SPL UNCLASSIFIED SECTION

  • each 30 mL contains: potassium 6 mg, sodium 32 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, light amber honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-328-5259

Other Safety Information

DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME.

DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

TAMPER-EVIDENT INNER UNIT. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.

DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 6 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

1-855-328-5259

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2021 GSK group of companies or its licensor.

Made in Canada

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0067-8204-01

THERAFLU

FLU RELIEF

MAX STRENGTH*

DAYTIME FORMULA

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Powerful fever fighting

formula that relieves:

/ Body ache

/ Headache

/ Sore throat pain

/ Cough

Honey & Elderberry Flavor

8.3 FL OZ (245.5mL)

NDC 0067-8205-01

THERAFLU

FLU RELIEF

MAX STRENGTH*

NIGHTTIME

HELPS YOU REST

Acetaminophen

Pain Reliever/Fever Reducer

Chlorpheniramine Maleate

Antihistamine

Dextromethorphan HBr

Cough Suppressant

Powerful fever fighting

formula that relieves:

/ Body ache

/ Headache

/ Sore throat pain

/ Cough

/ Runny nose

Honey & Elderberry Flavor

8.3 FL OZ (245.5mL)

NIGHTTIME

  • 2 – 8.3 FL OZ (245.5 mL) BOTTLES TOTAL 16.6 FL OZ (491 mL) USE AS DIRECTED
  • 1001529 Front Carton
1001529 Theraflu Flu Relief DT NT Max Strength Carton
1001529 Theraflu Flu Relief DT NT Max Strength Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2604635{1 (acetaminophen 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution) / 1 (acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution) } PackGPCK4
26046351 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution) / 1 daytime (acetaminophen 1000 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution) PackPSN4
2604562acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 30 mL Oral SolutionPSN4
1359455acetaminophen 500 MG / dextromethorphan HBr 15 MG in 15 mL Oral SolutionPSN4
2604562acetaminophen 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD4
1359455acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD4
26046351 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution) / 1 daytime (acetaminophen 1000 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution) PackSY4
26046351 nighttime (acetaminophen 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan HBr 1 MG/ML Oral Solution) / 1 daytime (acetaminophen 33.3 MG/ML / dextromethorphan HBr 1 MG/ML Oral Solution) PackSY4
2604562acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG per 30 mL Oral SolutionSY4
1359455acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG per 30 ML Oral SolutionSY4
1359455acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral SolutionSY4
2604562APAP 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSY4
1359455APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SolutionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0067-8206-012026-01-29C16284748780-149896155-ac82-586f-e063-e6dba90add90Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-8204-01Theraflu Flu Relief Max StrengthDaytime Nighttime Value Pack245.5 mL in 1 BOTTLESYRUP245.5 mL30 mg in 30mL4
0067-8205-01Theraflu Flu Relief Max StrengthDaytime Nighttime Value Pack245.5 mL in 1 BOTTLESYRUP245.5 mL30 mg in 30mL4
0067-8206-01Theraflu Flu Relief Max StrengthDaytime Nighttime Value Pack1 in 1 CARTONKIT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-8206-01ML - Milliliter0067-8206aa53d259-b04a-4a2d-b256-f7a97bc3fce612026-04-20
0067-8205-01ML - Milliliter0067-82054caa04a4-1310-43be-828c-7d6dca78e82a12025-12-16

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0067-82060067-8206-01
0067-82040067-8204-01
0067-82050067-8205-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
HONEYY9H1V576FHIACT
PEG-10 .BETA.-SITOSTERYL ETHERB2138XJ83GIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM GLUCONATER6Q3791S76IACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
HONEYY9H1V576FHIACT
PEG-10 .BETA.-SITOSTERYL ETHERB2138XJ83GIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
ACETAMINOPHEN362O9ITL9DACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu Flu Relief Max Strength Daytime Nighttime Value PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC3618ccf0-1f30-42e0-bb50-bfa45cf2b5832026-03-26WarningsExact identifier
ndc (package): 0067-8206-01
ndc (package): 0067-8204-01
ndc (package): 0067-8205-01
ndc (product): 0067-8206
ndc11 (package): 00067820601
ndc11 (package): 00067820401
ndc11 (package): 00067820501
spl id: 4df42ed2-1eee-3fa9-e063-6394a90abd10
spl set id: 3618ccf0-1f30-42e0-bb50-bfa45cf2b583
Theraflu Flu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC0324195f-506d-4747-990e-ad44e2a117d92026-01-07WarningsExact identifier
ndc (package): 0067-8204-01
ndc (product): 0067-8204
ndc11 (package): 00067820401
Theraflu Flu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC780907b8-34ba-4ec8-bcdf-b2a31bd111df2025-11-25WarningsExact identifier
ndc (package): 0067-8205-01
ndc (product): 0067-8205
ndc11 (package): 00067820501

Reported adverse events (FAERS/openFDA)#

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