FDA.reportPublic FDA data

THERAFLU

Manufacturer
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Effective date
2022-03-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:04:35

Label at a glance#

ProductTHERAFLU SINUS AND PAIN
Active ingredientACETAMINOPHEN, PHENIRAMINE MALEATE, 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 • temporarily reduces fever

Dosage and administration

• do not use more than directed • take every 4 hours, while symptoms persist. Do not take more than 5 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 p...

Storage and handling

• each packet contains : potassium 10 mg, sodium 51 mg • store at controlled room temperature 20-25°C (68-77°F). Protect product from heat and moisture.

Label contents#

Full prescribing information#

Active ingredients (in each packet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg
Pheniramine maleate 20 mg
Phenylephrine HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer
Antihistamine
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
  • 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
  • a breathing problem such as emphysema or chronic bronchitis
  • a sodium-restricted diet

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
  • may cause drowsiness
  • 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
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present. 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 5 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 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Other information

STORAGE AND HANDLING SECTION

  • each packet contains: potassium 10 mg, sodium 51 mg
  • store at controlled room temperature 20-25°C (68-77°F). Protect product from heat and moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, apple cinnamon flavors, citric acid, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, lecithin, maltodextrin, medium chain triglycerides, silicon dioxide, sodium chloride, sodium citrate, sucrose, triacetin, tribasic calcium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

1-855-328-5259

Additional information

SPL UNCLASSIFIED SECTION

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

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

©2019 GSK group of companies or its licensor.

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

SINUS CONGESTION & PRESSURE

RUNNY NOSE

HEADACHE

SNEEZING

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0067-7920-06

THERAFLU

SINUS & PAIN

Acetaminophen

Pain Reliever/Fever Reducer

Pheniramine Maleate

Antihistamine

Phenylephrine HCl

Nasal Decongestant

  • Sinus Congestion
  • Sinus Pressure
  • Runny Nose
  • Headache
  • Sneezing

6 PACKETS

APPLE CINNAMON FLAVOR

gsk

62000000042281

Theraflu Sinus and Pain 6 count carton
Theraflu Sinus and Pain 6 count carton

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0067-79200067-7920-01, 0067-7920-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
PHENIRAMINE MALEATENYW905655BACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MALTODEXTRIN7CVR7L4A2DIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SUCROSEC151H8M554IACT
TRIACETINXHX3C3X673IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT

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
0373b107-5250-4112-93a4-458f7cd74cc88914c6a5-050a-4e29-a940-7cdf887a0bde2023-10-31WarningsExact identifier
spl set id: 8914c6a5-050a-4e29-a940-7cdf887a0bde

Reported adverse events (FAERS/openFDA)#

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