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

Drug Details [pdf]

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

$Y:\HAL-CH Drug Listing\CH WORKING\Theraflu Berry Burst 0067-6800\Theraflu Severe Cold Relief Berry Burst 6 Packets.JPG$

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-6800
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	PINK (Pink-purple)	Score
Shape		Size
Flavor	BERRY (Burst)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 0067-6800-02	6 in 1 CARTON; Type 0: Not a Combination Product	01/20/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	01/20/2022

Labeler - Haleon US Holdings LLC (079944263)

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

Theraflu Severe Cold relief Nighttime by

Drug Labeling and Warnings

Drug Details [pdf]

Do Not Use

Ask a 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,

Keep out of reach of children.

Age	Dose
adults and children 12 years of age and over	one packet
children under 12 years of age	do not use