THERAFLU SEVERE COLD RELIEF DAYTIME BERRY BURST- acetaminophen, dextromethorphan hbr, phenylephrine hydrochloride powder 
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

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
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.
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
trouble urinating due to an enlarged prostate gland
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 the blood thinning drug warfarin

When using this product

do not exceed recommended dosage

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 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 20 mg
phenylketonurics: contains phenylalanine 14 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 blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, 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

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.com

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.

PA_620000000201493

HOT LIQUID THERAPY
that relieves:

Nasal and sinus congestion

Cough

Sore throat pain

Headache

Fever

CARTON
RECYCLE

Principal Display Panel

HALEON

NDC 0067-6800-02

MULTI-SYMPTOM COLD RELIEF

THERAFLU

SEVERE

COLD RELIEF

DAYTIME FORMULA

ACETAMINOPHEN
Paint Reliever/Fever Reducer

Dextromethorphan HBr
Cough Suppressant

PHENYLEPHRINE HCl
Nasal Decongestant

Hot liquid therapy
that relieves:

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

Berry Burst Flavor

6 PACKETS

Y:\HAL-CH Drug Listing\CH WORKING\Theraflu Berry Burst 0067-6800\Theraflu Severe Cold Relief Berry Burst 6 Packets.JPG
THERAFLU SEVERE COLD RELIEF DAYTIME BERRY BURST 
acetaminophen, dextromethorphan hbr, phenylephrine hydrochloride powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6800
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)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ASPARTAME (UNII: Z0H242BBR1)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Product Characteristics
ColorPINK (Pink-purple) Score    
ShapeSize
FlavorBERRY (Burst) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6800-026 in 1 CARTON; Type 0: Not a Combination Product01/20/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/20/2022
Labeler - Haleon US Holdings LLC (079944263)

Revised: 2/2024
Document Id: 77b6db34-5ac4-46a5-9d6d-1c4cc83a9ba9
Set id: ebbb2f4b-ba84-40ad-96f6-60225119a33b
Version: 3
Effective Time: 20240227
 
Haleon US Holdings LLC