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  5. Label Information: Theraflu Severe Cold Relief Soft Chews

FDA Label for Theraflu Severe Cold Relief Soft Chews

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH CHEWABLE TABLET)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. GENERIC SECTION
    16. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Theraflu Severe Cold Relief Soft Chews Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each Chewable Tablet)



Acetaminophen 325 mg

Dextromethorphan equivalent to 10 mg Dextromethorphan HBr


Purposes



Pain reliever/Fever reducer

Cough suppressant


Uses



  • ▪temporarily relieves these symptoms due to a cold:
    • ▪minor aches and pains
    • ▪sore throat pain
    • ▪headache
    • ▪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
  • ▪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



  • ▪fever gets worse or lasts more than 3 days
  • ▪redness or swelling is present
  • ▪new symptoms occur
  • ▪pain or cough 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



  • ▪do not use more than directed
  • ▪do not take more than 10 chewable tablets in 24 hours unless directed by a doctor. Take every 4 hours, while symptoms persist.

    • Age

    Dose

    adults and children 12 years of age and over

    take 2 chewable tablets every 4 hours

    children under 12 years of age

    do not use


Other Information



  • ▪each chewable tablet contains: potassium 10 mg, sodium 6 mg
  • ▪store at a controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients



calcium gluconate monohydrate, carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk


Questions Or Comments?



call 1-855-328-5359


Generic Section



Do Not Use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION” is broken or missing.

Distributed by: Haleon, Warren, NJ 07059

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

Pat. Info www.productpats.com

©2024 Haleon group of companies or its licensor.

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Peel Here


Package/Label Principal Display Panel



NEW

THERAFLU

SEVERE COLD RELIEF

SOFT CHEWS

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

FAST relief ANYWHERE

cough / sore throat / headache / body aches / fever

20 CHEWABLE TABLETS

Chew tablets completely before swallowing

Apple Cinnamon Flavor


* Please review the disclaimer below.