THERAFLU  SEVERE COLD RELIEF NIGHTTIME WITH HONEY ELDERBERRY FLAVOR- acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solution 
Haleon US Holdings LLC

----------

Drug Facts

Active ingredients (in each packet)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

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:

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 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

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

Age

Dose

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, acetic acid, aspartame, citric acid, elderberry juice concentrate, FD&C blue no. 1, FD&C red no. 40, honey solids, isomalt, maltodextrin, natural flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, sunflower lecithin, triacetin, tribasic calcium phosphate

Questions or comments?

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

©2022 GSK group of companies or its licensor.

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

Principal Display Panel

THERAFLU

NEW FLAVOR

MULTI - SYMPTOM COLD RELIEF

SEVERECOLD RELIEF

NIGHTTIME

HELPS YOU REST

Acetaminophen
Pain Reliever/Fever Reducer

Diphenhydramine HCl
Antihistamine/Cough Suppressant

Phenylephrine HCl
Nasal Decongestant

Hot liquid therapy
that relieves:

/ Nasal and sinus congestion
/ Cough
/ Sore throat pain
/ Headache
/ Runny nose
/ Fever

Honey Elderberry

6 PACKETS

PA 62000000200565 – Carton Front

Theraflu SC Relief NT with Honey Elderberry 6 ct carton
THERAFLU   SEVERE COLD RELIEF NIGHTTIME WITH HONEY ELDERBERRY FLAVOR
acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8212
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 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)  
ACETIC ACID (UNII: Q40Q9N063P)  
ASPARTAME (UNII: Z0H242BBR1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HONEY (UNII: Y9H1V576FH)  
ISOMALT (UNII: S870P55O2W)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
TRIACETIN (UNII: XHX3C3X673)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Product Characteristics
Colorwhite (off-white, beige, brown) Score    
ShapeSize
FlavorHONEY (Elderberry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-8212-016 in 1 CARTON05/01/2023
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01205/01/2023
Labeler - Haleon US Holdings LLC (079944263)

Revised: 3/2024
Document Id: 132a7bfc-7f1c-8436-e063-6394a90a5238
Set id: d4ce06aa-776f-45e4-a1a6-9cf13797048f
Version: 2
Effective Time: 20240308
 
Haleon US Holdings LLC