FDA.reportPublic FDA data

Theraflu Severe Cold relief Nighttime

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:09:36

Label at a glance#

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

Indications and uses

temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion 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 take every 4 hours, while symptoms persist. Do not take more than 6 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. Consumer 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 500 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a cold:
    • minor aches and pains
    • minor sore throat pain
    • headache
    • nasal and sinus congestion
    • 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
  • 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
  • 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

  • do not exceed recommended dosage
  • 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

  • nervousness, dizziness, or sleeplessness occurs
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • pain, cough or nasal congestion gets worse or last 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
  • take every 4 hours, while symptoms persist. Do not take more than 6 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. Consumer 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

OTHER SAFETY INFORMATION

  • each packet contains: potassium 10 mg, sodium 23 mg
  • phenylketonurics: contains phenylalanine 13 mg per packet
  • store at controlled room temperature 20-25°C (68-77°F). Protect product from heat and moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, aspartame, FD&C yellow no. 6, flavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

Questions or Comments?

OTC - QUESTIONS SECTION

call 1-800-328-5259

Generic Section

SPL UNCLASSIFIED SECTION

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

1-855-328-5259

Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
©2022 GSK group of companies or its licensor.
Trademarks are owned by or licensed to the GSK group of companies. 62000000075407

HOT LIQUID THERAPY
that relieves:

Nasal and sinus congestion Cough

Sore throat pain Headache

Runny nose Fever

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.com

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

CARTON
RECYCLE

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0067-6801-02

MULTI-SYMPTOM COLD RELIEF

THERAFLU

SEVERE

COLD RELIEF

NIGHTTIME

ACETAMINOPHEN
PAIN RELIEVER/FEVER REDUCER

DIPHENHYDRAMINE HCl
ANTIHISTAMINE/COUGH SUPPRESSANT

PHENYLEPHRINE HCl
NASAL DECONGESTANT

HELPS YOU REST*

Hot liquid therapy
that relieves:

/Nasal and sinus congestion
/ Cough
/ Sore throat pain
/ Headache
/ Runny nose
/ Fever

Citrus & Green Tea

6 PACKETS

Theraflu Sever Cold Relief Citrus Green Tea 6 Packets
Theraflu Sever Cold Relief Citrus Green Tea 6 Packets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1659175acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Powder for Oral SolutionPSN2
1659175acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSCD2
1659175acetaminophen 500 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for OralSY2
1659175acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSY2
1659175APAP 500 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE 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
0067-6801-022024-01-30C16284748780-11030e365-211c-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-6801-02Theraflu Severe Cold relief Nighttime6 in 1 CARTONPOWDER62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-6801THERAFLU SEVERE COLD RELIEF NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [HALEON US HOLDINGS LLC]2Current NDC, 1 package rows20240310_0d3b1bea-e2ca-4e07-8ae5-60627d230c96.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0067-68010067-6801-02

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
ASPARTAMEZ0H242BBR1IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SUCROSEC151H8M554IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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 Severe Cold relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC0d3b1bea-e2ca-4e07-8ae5-60627d230c962024-03-08WarningsExact identifier
ndc (package): 0067-6801-02
ndc (product): 0067-6801
ndc11 (package): 00067680102
spl id: 132cdb61-2615-2863-e063-6394a90a7e5a
spl set id: 0d3b1bea-e2ca-4e07-8ae5-60627d230c96

Reported adverse events (FAERS/openFDA)#

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