FDA.reportPublic FDA data

Theraflu

Manufacturer
Haleon US Holdings LLC
Effective date
2025-11-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:16:15

Label at a glance#

ProductTheraflu Severe Cold Relief Nighttime
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms to a cold: minor aches and pains minor sore throat pain headache runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever

Dosage and administration

do not use more than directed measure the dose correctly using the enclosed dosing cup take every 4 hours in dosing cup provided, while symptoms persist do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor Age Dose Adults and children 12 years of age and over 30 mL Children under 12 years of age do not use

Label contents#

Full prescribing information#

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms to a cold:
    • minor aches and pains
    • minor sore throat pain
    • headache
    • runny nose
    • sneezing
    • itchy nose or throat
    • itchy, watery eyes due to hay fever
    • cough due to minor throat and bronchial irritation
  • 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.
  • with any other product containing diphenhydramine, even one used on the skin
  • to sedate a child or make a child sleepy

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 sedatives or tranquilizers
  • taking the blood thinning drug warfarin

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

  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • pain or cough gets worse or lasts more than 7 days
  • 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
  • take every 4 hours in dosing cup provided, while symptoms persist
  • do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor

Age

Dose

Adults and children 12 years of age and over

30 mL

Children under 12 years of age

do not use

Other information

SPL UNCLASSIFIED SECTION

  • each 30 mL contains:potassium 30 mg, sodium 13 mg
  • store at controlled room temperature 20°-25°C (68° – 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, maltitol solution, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

OTC - QUESTIONS SECTION

1-855-328-5259

Other Information

SPL UNCLASSIFIED SECTION

Distributed by: Haleon, Warren, NJ 07059 Made in Mexico Trademarks are owned by or licensed to the Haleon group of companies. ©2024 Haleon group of companies or its licensor. Pat. Info www.productpats.com

PEEL BACK HERE

DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MULTI-SYMPTOM COLD RELIEF

THERAFLU

SEVERE

COLD RELIEF

NIGHTTIME

Acetaminophen

Pain Reliever/Fever Reducer

Diphenhydramine HCl

Antihistamine/Cough Suppressant

HELPS YOU REST*

Powerful formula that relieves:

/ Cough

/ Sore throat pain

/ Head and body ache

/ Fever

/ Runny nose

/ Sneezing

8.3 FL OZ (245.5 mL)

Berry Flavor

*Temporarily controls cough to help you rest. This is not a sleep-aid.

Theraflu Severe Cold Relief Nighttime 8.3 oz
Theraflu Severe Cold Relief Nighttime 8.3 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1294607acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG in 30 mL Oral SolutionPSN4
1294607acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML Oral SolutionSCD4
1294607APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML Oral SolutionSY4
1294607APAP 325 MG / diphenhydramine hydrochloride 12.5 MG per 15 ML Oral SolutionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-0105-08TherafluSevere Cold Relief Nighttime245.5 mL in 1 BOTTLESYRUP245.54

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0067-01050067-0105-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACESULFAME POTASSIUM23OV73Q5G9IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
MALTITOLD65DG142WKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLCc24b9489-208c-472b-8ae5-c6e86c12e04d2025-11-13WarningsExact identifier
ndc (package): 0067-0105-08
ndc (product): 0067-0105
ndc11 (package): 00067010508
spl id: 438014e3-6d78-1332-e063-6394a90afc47
spl set id: c24b9489-208c-472b-8ae5-c6e86c12e04d
Theraflu Severe Cold ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENPHYDRAMINE HCL, GUAIFENESINHaleon US Holdings LLCb01cc9f5-53f2-40d8-acf1-6de180b3d0bf2024-10-14WarningsExact identifier
ndc (package): 0067-0105-08
ndc11 (package): 00067010508

Reported adverse events (FAERS/openFDA)#

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