THERAFLU FLU AND SORE THROAT- acetaminophen, pheniramine maleate, phenylephrine hcl powder, for solution 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

----------

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

temporarily relieves these symptoms due to a cold:
o
minor aches and pains
o
minor sore throat pain
o
headache
o
nasal and sinus congestion
o
runny nose
o
sneezing
o
itchy nose or throat
o
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 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 1-855-328-5259

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

©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

Nasal Congestion
Sore Throat Pain
Headache
Fever
Body Ache
Runny Nose

6 PACKETS

APPLE CINNAMON FLAVOR

gsk

62000000033902

Theraflu Flu and Sore Throat 6 count carton
THERAFLU  FLU AND SORE THROAT
acetaminophen, pheniramine maleate, phenylephrine hcl powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-7916
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
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    
ShapeSize
FlavorAPPLE, CINNAMON (Natural Apple Cinnamon) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-7916-066 in 1 CARTON05/13/200512/31/2022
1NDC:0067-7916-011 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01205/13/200512/31/2022
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 10/2023
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC