THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder 
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.

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Drug Facts

Active ingredients (in each packet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Antihistamine/cough suppressant

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
cough due to minor throat and bronchial irritation
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 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

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

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product

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

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,

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 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 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Other 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

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

Questions or Comments?

call 1-800-452-0051

Principal Display Panel

NDC 0067-8124-06

THERAFLU®

NIGHTTIME

MULTI-SYMPTOM

SEVERE COLD

ACETAMINOPHEN-PAIN RELIEVER/FEVER REDUCER

DIPHENHYDRAMINE HCl-ANTIHISTAMINE/COUGH SUPPRESSANT

PHENYLEPHRINE HCl-NASAL DECONGESTANT

NASAL CONGESTION
SORE THROAT PAIN
COUGH • HEADACHE
BODY ACHE • FEVER
RUNNY NOSE
SNEEZING

6 PACKETS

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

www.theraflu.com

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

TAMPER EVIDENT INNER UNIT

DO YOU USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN.

Lipton is a registered trademark of the Unilever Group of Companies and is used under license.

Distributed by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622

©2015

Made in Canada

12211

Theraflu Nighttime Multi-Symptom Severe Cold 6 countt carton
THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER 
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8124
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ASPARTAME (UNII: Z0H242BBR1)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Product Characteristics
ColorWHITE (white to off-white) , YELLOW (yellow, beige/brown granules) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-8124-066 in 1 CARTON; Type 0: Not a Combination Product07/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/15/2015
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
GSK Consumer Health, Inc.129836151MANUFACTURE(0067-8124) , ANALYSIS(0067-8124) , PACK(0067-8124) , LABEL(0067-8124)

Revised: 6/2021
Document Id: 16be0a08-f1de-4da9-a689-c1e71bde4926
Set id: ef42d2a3-1bab-4527-8e1e-54e8749cc7b5
Version: 5
Effective Time: 20210624
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC