FDA.reportPublic FDA data

Theraflu-D Flu Relief Max Strength plus Nasal Decongestant

Manufacturer
Haleon US Holdings LLC
Effective date
2024-05-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:50

Label at a glance#

ProductTheraflu-D Flu Relief Max Strength plus Nasal Decongestant
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to a common cold or flu: headache minor aches and pains minor sore throat pain cough due to minor throat and bronchial irritation nasal and sinus congestion 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 every 6 hours children under 12 years...

Label contents#

Full prescribing information#

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 1000 mg

Dextromethorphan HBr 30 mg

Pseudoephedrine HCl 60 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a common cold or flu:
    • headache
    • minor aches and pains
    • minor sore throat pain
    • cough due to minor throat and bronchial irritation
    • 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 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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • 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

  • nervousness, dizziness, or sleeplessness occurs
  • 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.

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
  • Age
  • Dose
  • adults and children 12 years of age and over
  • 30 mL every 6 hours
  • children under 12 years of age
  • do not use

Other information

SPL UNCLASSIFIED SECTION

  • each 30 mL contains: sodium 26 mg
  • store at 20-25°C (68-77°F). Do not refrigerate. Keep bottle tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, anhydrous citric acid, carboxymethylcellulose sodium, D&C red no. 33, FD&C red no. 40, glycerin, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-855-328-5259

Additional Information

OTHER SAFETY INFORMATION

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

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

DO NOT USE IF TEAR BAND ON CAP IS BROKEN OR MISSING.

Distributed by: Haleon

Warren, NJ 07059

Made in Canada

©2024 Haleon group of companies or its licensor.

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

Pat. Info www.productpats.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MULTI-SYMPTOM RELIEF NEWHALEON

THERAFLU-D

FLU RELIEF

MAX STRENGTH*

+ NASAL DECONGESTANT

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Pseudoephedrine HCI

Nasal Decongestant

Fast, Powerful Multi-Symptomrelief of:

/ Fever

/ Nasal congestion

/ Sinus Pressure

/ Head & Body Ache

/ Sore Throat Pain

/ Cough

Cherry Flavor

8.0 FL OZ (237 mL)

62000000209289 Carton

Theraflu-D Flu Relief MS Nasal Decon 8.0 fl oz
Theraflu-D Flu Relief MS Nasal Decon 8.0 fl oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1369927acetaminophen 1000 MG / dextromethorphan HBr 30 MG / pseudoephedrine HCl 60 MG in 30 mL Oral SolutionPSN1
1369927acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML / pseudoephedrine hydrochloride 2 MG/ML Oral SolutionSCD1
1369927acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG / pseudoephedrine hydrochloride 60 MG per 30 ML Oral SolutionSY1
1369927APAP 1000 MG / dextromethorphan hydrobromide 30 MG / pseudoephedrine hydrochloride 60 MG per 30 ML Oral SolutionSY1
1369927APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Pseudoephedrine Hydrochloride 2 MG/ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-0115-01Theraflu-D Flu Relief Max Strength plus Nasal Decongestant1 in 1 CARTONSYRUP11
0067-0115-01Theraflu-D Flu Relief Max Strength plus Nasal Decongestant237 mL in 1 BOTTLESYRUP2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-0115THERAFLU-D FLU RELIEF MAX STRENGTH PLUS NASAL DECONGESTANT (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL) SYRUP [HALEON US HOLDINGS LLC]1Current NDC, 2 package rows20240619_e35cb719-9e7d-4b2b-81a4-29e147dd74fa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-0115-01ML - Milliliter0067-0115e217d224-150f-40e5-a845-77f46910beca12024-09-09

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0067-01150067-0115-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB

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
Theraflu-D Flu Relief Max Strength plus Nasal DecongestantACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCLHaleon US Holdings LLCe35cb719-9e7d-4b2b-81a4-29e147dd74fa2024-05-03WarningsExact identifier
ndc (package): 0067-0115-01
ndc (product): 0067-0115
ndc11 (package): 00067011501
spl id: 178df809-0bd7-7259-e063-6294a90a2b21
spl set id: e35cb719-9e7d-4b2b-81a4-29e147dd74fa

Reported adverse events (FAERS/openFDA)#

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