THERAFLU FLU RELIEF MAX STRENGTH DAYTIME- acetaminophen, dextromethorphan hbr syrup

Theraflu Flu Relief Max Strength by

Drug Labeling and Warnings

Theraflu Flu Relief Max Strength 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

Dextromethorphan HBr 30 mg

Purposes

Pain reliever/Fever reducer

Cough suppressant

Uses

• temporarily relieves these symptoms due to a common cold or flu:
  • headache
  • minor aches and pains
  • cough due to minor throat and bronchial irritation
  • minor sore throat pain
• 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
• 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

Stop use and ask a doctor if

• pain or cough 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
• children under 12 years of age:
  • do not use

Other information

• each 30 mL contains: potassium 5 mg, sodium 34 mg
• store at controlled room temperature 20-25°C (68-77°F).

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

Questions or comments?

1-855-328-5259

Additional Information

PEEL BACK HERE

DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD. USE AS DIRECTED

DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.

*Maximum Strength per 6 hour dose.

PARENTS: Learn about teen medicine abuse

www.StopMedicineAbuse.org

Pat. Info www.productpats.com

Principal Display Panel

THERAFLU

FLU RELIEF

MAX STRENGTH*

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

DAYTIME FORMULA

Powerful fever fighting formula that relieves:

/ Body ache

/ Headache

/ Sore throat pain

/ Cough

Honey & Elderberry Flavor

8.3 FL OZ (245.5mL)

INGREDIENTS AND APPEARANCE

THERAFLU FLU RELIEF MAX STRENGTH  DAYTIME
acetaminophen, dextromethorphan hbr syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-8204
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
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
HONEY (UNII: Y9H1V576FH)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY (Elderberry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-8204-01	245.5 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	06/27/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/27/2022

Labeler - Haleon US Holdings LLC (079944263)