THERAFLU FLU AND SORE THROAT- acetaminophen, pheniramine maleate, phenylephrine hcl powder, for solution

Theraflu by

Drug Labeling and Warnings

Theraflu by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each packet)

Acetaminophen, 650 mg
Pheniramine maleate, 20 mg
Phenylephrine HCl, 10 mg

Purposes

Pain reliever/fever reducer
Antihistamine
Nasal decongestant

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

Warnings

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

• 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 a 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

• 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

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

• 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

• 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,

ask a health care professional before use.

Keep out of reach of children.

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

• 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

• 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

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?

call 1-800-452-0051

Principal Display

NDC: 0067-7916-06

THERAFLU®

FLU & SORE THROAT

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER

PHENIRAMINE MALEATE – ANTIHISTAMINE

PHENYLEPHRINE HCl – NASAL DECONGESTANT

• NASAL CONGESTION
• SORE THROAT
• HEADACHE
• BODY ACHE
• RUNNY NOSE
• FEVER

Apple Cinnamon

Flavor

6 PACKETS

FLU & SORE THROAT

Theraflu® provides powerful relief from your severe cold and flu symptoms.

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

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

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059

©2017 GSK group of companies or its licensor. All rights reserved.

62000000010977

INGREDIENTS AND APPEARANCE

THERAFLU  FLU AND SORE THROAT
acetaminophen, pheniramine maleate, phenylephrine hcl powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-7916
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M)	PHENIRAMINE MALEATE	20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)
TRIACETIN (UNII: XHX3C3X673)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Product Characteristics
Color		Score
Shape		Size
Flavor	APPLE, CINNAMON (Natural Apple Cinnamon)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-7916-06	6 in 1 CARTON	05/13/2005
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/13/2005

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)