THERAFLU-D FLU RELIEF MAX STRENGTH PLUS NASAL DECONGESTANT NIGHTTIME- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hcl syrup

Theraflu-D Flu Relief Max Strength plus Nasal Decongestant by

Drug Labeling and Warnings

Theraflu-D Flu Relief Max Strength plus Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by Haleon US Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 30 mL)

Acetaminophen 1000 mg

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg

Pseudoephedrine HCl 60 mg

Purposes

Pain reliever/Fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses

• temporarily relieves these symptoms due to a common cold or flu:
  • headache
  • minor aches and pains
  • minor sore throat pain
  • runny nose
  • cough due to minor throat and bronchial irritation
  • nasal and sinus congestion
• 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
• 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 the blood thinning drug warfarin
• taking sedatives or tranquilizers

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
• pain, cough or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• 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
• measure the dose correctly using the enclosed dosing cup
• adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist
• do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor
• children under 12 years of age: do not use

• Age:
  • Dose
• adults and children 12 years of age and over:
  • 30 mL every 6 hours
• children under 12 years of age:
  • do not use

Other information

• each 30 mL contains: sodium 26 mg
• store at 20-25°C (68-77°F). Do not refrigerate. Keep bottle tightly closed.

Inactive ingredients

alcohol, anhydrous citric acid, carboxymethylcellulose sodium, D&C red no. 33, FD&C red no. 40, glycerin, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

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

DO NOT USE IF TEAR BAND ON CAP IS BROKEN OR MISSING.

Distributed by: Haleon

Warren, NJ 07059

Made in Canada

©2024 Haleon group of companies or its licensor.

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

Pat. Info www.productpats.com

Principal Display Panel

MULTI-SYMPTOM RELIEF NEWHALEON

THERAFLU-D

FLU RELIEF

MAX STRENGTH*

+ NASAL DECONGESTANT

NIGHTTIME

Acetaminophen

Pain Reliever/Fever Reducer

Chlorpheniramine Maleate

Antihistamine

Dextromethorphan HBr

Cough Suppressant

Pseudoephedrine HCI

Nasal Decongestant

Fast, Powerful Multi-Symptomrelief of:

/ Fever

/ Nasal congestion

/ Sinus Pressure

/ Head & Body Ache

/ Sore Throat Pain

/ Cough

/ Runny Nose

/ Sneezing

Cherry Flavor

8.0 FL OZ (237 mL)

62000000209276 Carton Front

INGREDIENTS AND APPEARANCE

THERAFLU-D FLU RELIEF MAX STRENGTH PLUS NASAL DECONGESTANT   NIGHTTIME
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hcl syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-0114
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	1000 mg  in 30 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	red (Clear)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-0114-01	1 in 1 CARTON	06/19/2024
1		237 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/19/2024

Labeler - Haleon US Holdings LLC (079944263)