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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Antihistamine Nasal decongestant
Authorization status:
OTC monograph final
Authorization number:
0067-7916-01, 0067-7916-06

THERAFLU FLU AND SORE THROAT- acetaminophen, pheniramine maleate, phenylephrine

hcl powder, for solution

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active ingredients (in each packet)

Acetaminophen 650 mg

Pheniramine maleate 20 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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

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

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

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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.

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

taking sedatives or tranquilizers

taking the blood thinning drug warfarin

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

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 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

Age

Dos e

adults and children 12 years of age and over

one packet

children under 12 years of age

do not use

Other information

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 1-855-328-5259

Additional information

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

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.

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.

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.

©2019 GSK group of companies or its licensor.

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

FLU & SORE THROAT

NASAL CONGESTION

SORE THROAT PAIN

HEADACHE

FEVER

BODY ACHES

RUNNY NOSE

Principal Display Panel

NDC 0067-7916-06

THERAFLU

FLU & SORE THROAT

Acetaminophen

Pain Reliever/Fever Reducer

Pheniramine Maleate

Antihistamine

Phenylephrine HCl

Nasal Decongestant

6 PACKETS

APPLE CINNAMON FLAVOR

gs k

62000000033902

Nasal Congestion

Sore Throat Pain

Headache

Fever

Body Ache

Runny Nose

THERAFLU FLU AND SORE THROAT

acetaminophen, pheniramine maleate, phenylephrine hcl powder, for solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 0 6 7-79 16

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

6 50 mg

PHENIRAMINE MALEATE (UNII: NYW9 0 56 55B) (PHENIRAMINE - UNII:134FM9 ZZ6 M)

PHENIRAMINE MALEATE

20 mg

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

PHENYLEPHRINE

10 mg

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

UNII:1WS29 7W6 MV)

HYDROCHLORIDE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM CITRATE, UNSPECIFIED FO RM (UNII: 1Q73Q2JULR)

SUCRO SE (UNII: C151H8 M554)

TRIACETIN (UNII: XHX3C3X6 73)

TRIBASIC CALCIUM PHO SPHATE (UNII: 9 1D9 GV0 Z28 )

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

APPLE, CINNAMON (Natural Apple Cinnamo n)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 0 6 7-79 16 -0 6

6 in 1 CARTON

0 5/13/20 0 5

1

NDC:0 0 6 7-79 16 -0 1

1 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 5/13/20 0 5

Labeler -

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 8/2020

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