FDA.reportPublic FDA data

Theraflu Flu Relief Max Strength

Manufacturer
Haleon US Holdings LLC
Effective date
2025-05-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:01:15

Label at a glance#

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

Indications and uses

temporarily relieves these symptoms due to a common cold or flu: 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 take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. if using a microwave, add contents of one packet to...

Label contents#

Full prescribing information#

Active ingredients (in each packet)

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 or flu:
    • 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
  • 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

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
  • take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor.
  1. Age
  1. Dose
  1. adults and children 12 years of age and over
  1. one packet
  1. children under 12 years of age
  1. do not use
  • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
  • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Other information

SPL UNCLASSIFIED SECTION

  • each packet contains:potassium 10 mg, sodium 20 mg
  • phenylketonurics:contains phenylalanine 19.6 mg per packet
  • store at a controlled room temperature at 20 - 25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

1-855-297-3031

Active ingredients (in each packet)

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 or flu:
    • 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 MAOI, 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
  • take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor.
  1. Age
  1. Dose
  1. adults and children 12 years of age and over
  1. one packet
  1. children under 12 years of age
  1. do not use
  • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
  • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating.

    Do not overheat

Other information

SPL UNCLASSIFIED SECTION

  • each packet contains:potassium 5 mg, sodium 22 mg
  • phenylketonurics:contains phenylalanine 12.9 mg per packet
  • store at a controlled room temperature at 20 - 25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

1-855-297-3031

Additional Information

OTHER SAFETY INFORMATION

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

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.

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 BOTH PRODUCTS AT THE SAME TIME
OR TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

*Maximum Strength per 6 hour dose

TAMPER-EVIDENT INNER UNIT. DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN.

1-855-297-3031

Distributed by: Haleon, Warren, NJ 07059

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

©2025 Haleon group of companies or its licensor.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MULTI-SYMPTOM FLU RELIEF

HALEON

THERAFLU

FLU RELIEFMAX STRENGTH*

6 x DAYTIME

AcetaminophenPain Reliever/Fever Reducer

Dextromethorphan HBrCough Suppressant

6 x NIGHTTIME

AcetaminophenPain Reliever/Fever Reducer

Chlorpheniramine MaleateAntihistamine

Dextromethorphan HBrCough Suppressant

Hot liquid therapythat relieves:

/ Fever

/ Body ache

/ Headache

/ Sore throat pain

/ Cough

/ Runny nose (Nighttime only)

6 DAYTIME PACKETS

6 NIGHTTIME PACKETS

12 TOTAL PACKETS

Honey Lemon Flavor

USE ONLY AS DIRECTED

62000000214400 Front Carton

Theraflu Flu Relief MS DT NT Powder 12ct.jpg
Theraflu Flu Relief MS DT NT Powder 12ct.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2636659{1 (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) / 1 (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) } PackGPCK5
2636659{1 daytime (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) / 1 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) } PackPSN5
2636658acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Powder for Oral SolutionPSN5
2636656acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionPSN5
2636658acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionSCD5
2636656acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionSCD5
2636659{1 daytime (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution) } PackSY5
2636658acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Granules for Oral SolutionSY5
2636656acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Granules for Oral SolutionSY5
2636658APAP 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionSY5
2636656APAP 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionSY5

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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-7921-02Theraflu Flu Relief Max StrengthDaytime Nighttime Combo Pack6 in 1 CARTONPOWDER630 mg5
0067-7922-02Theraflu Flu Relief Max StrengthDaytime Nighttime Combo Pack6 in 1 CARTONPOWDER64 mg5
0067-7923-02Theraflu Flu Relief Max StrengthDaytime Nighttime Combo Pack1 in 1 CARTONKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-7921THERAFLU FLU RELIEF MAX STRENGTH DAYTIME NIGHTTIME COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) KIT [HALEON US HOLDINGS LLC]5Current NDC20250521_812a093f-cf83-4f7a-927a-1b5695be7f90.zip
0067-7922THERAFLU FLU RELIEF MAX STRENGTH DAYTIME NIGHTTIME COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) KIT [HALEON US HOLDINGS LLC]5Current NDC20250521_812a093f-cf83-4f7a-927a-1b5695be7f90.zip
0067-7923THERAFLU FLU RELIEF MAX STRENGTH DAYTIME NIGHTTIME COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) KIT [HALEON US HOLDINGS LLC]5Current NDC, Legacy NDC, 3 package rows20250521_812a093f-cf83-4f7a-927a-1b5695be7f90.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-7921-02EA - Each0067-792124e2c547-7edc-4510-9afd-86d599347b7612025-11-13

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0067-79230067-7923-02
0067-79210067-7921-02
0067-79220067-7922-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACESULFAME POTASSIUM23OV73Q5G9IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ASPARTAMEZ0H242BBR1IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SOYBEAN LECITHIN1DI56QDM62IACT
SUCROSEC151H8M554IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ASPARTAMEZ0H242BBR1IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SOYBEAN LECITHIN1DI56QDM62IACT
SUCROSEC151H8M554IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
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 Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC812a093f-cf83-4f7a-927a-1b5695be7f902025-05-19WarningsExact identifier
ndc (package): 0067-7923-02
ndc (package): 0067-7921-02
ndc (package): 0067-7922-02
ndc (product): 0067-7923
ndc11 (package): 00067792102
ndc11 (package): 00067792302
ndc11 (package): 00067792202
spl id: 357ca5d8-877d-8cce-e063-6294a90a5cae
spl set id: 812a093f-cf83-4f7a-927a-1b5695be7f90
Theraflu Flu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC51c7628a-c7cf-498f-8fb1-db732e2b8b6e2025-05-16WarningsExact identifier
ndc (package): 0067-7922-02
ndc (product): 0067-7922
ndc11 (package): 00067792202
Theraflu Flu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLCa1405038-80f2-45e5-bd8c-8c6b0ee348be2025-05-15WarningsExact identifier
ndc (package): 0067-7921-02
ndc (product): 0067-7921
ndc11 (package): 00067792102

Reported adverse events (FAERS/openFDA)#

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