THERAFLU  SEVERE COLD RELIEF DAYTIME WITH HONEY GINGER FLAVOR- acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution 
Haleon US Holdings LLC

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Drug Facts

Active ingredients (in each packet)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/Fever reducer

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

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 lasts 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

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, aspartame, citric acid, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, honey solids, maltodextrin, medium chain triglycerides, natural flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, 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.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

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

Acetaminophen
Pain Reliever/Fever Reducer

Dextromethorphan HBr
Cough Suppressant

Phenylephrine HCl
Nasal Decongestant

DAYTIME FORMULA

Hot liquid therapy
that relieves:

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

Honey Ginger

6 PACKETS

PA 62000000200567 – Carton Front

Theraflu Severe CR Daytime 6 ct carton
THERAFLU   SEVERE COLD RELIEF DAYTIME WITH HONEY GINGER FLAVOR
acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8211
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
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)  
HONEY (UNII: Y9H1V576FH)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
TRIACETIN (UNII: XHX3C3X673)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Product Characteristics
Colorwhite (off-white, beige, brown) Score    
ShapeSize
FlavorHONEY (Ginger) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-8211-016 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: 1329d128-9336-8869-e063-6294a90ae0d3
Set id: 18dcede2-5a38-40fa-93fe-48acdd6a7cf1
Version: 3
Effective Time: 20240308
 
Haleon US Holdings LLC