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  5. Label Information: Theraflu Severe Cold Relief Nighttime Soft Chews

FDA Label for Theraflu Severe Cold Relief Nighttime 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. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONSOR COMMENTS?
    16. GENERIC SECTION
    17. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Theraflu Severe Cold Relief Nighttime 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

Diphenhydramine HCl 12.5 mg


Purposes



Pain reliever/Fever reducer

Antihistamine/Cough suppressant


Uses



  • ▪temporarily relieves these symptoms due to a cold:
    • ▪minor aches and pains
    • ▪sore throat pain
    • ▪headache
    • ▪runny nose
    • ▪sneezing
    • ▪itchy nose or throat
    • ▪itchy, watery eyes due to hay fever
    • ▪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.
  • ▪with any other product containing diphenhydramine, even one used on the skin

Ask A Doctor Before Use If You Have



  • ▪liver disease
  • ▪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 sedatives or tranquilizers
  • ▪taking the blood thinning drug warfarin

When Using This Product



  • ▪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



  • ▪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: calcium 10 mg, potassium 10 mg, sodium, 7 mg
  • ▪store at a controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients



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


Questionsor Comments?



call 1-855-328-5259


Generic Section



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


Package/Label Principal Display Panel



NEW

THERAFLU

SEVERE COLD RELIEF

NIGHTTIME

Soft CHEWS

Acetaminophen

Pain Reliever/Fever Reducer

Diphenhydramine HCl

Antihistamine/Cough Suppressant

FAST relief ANYWHERE

fever / cough / headache / body aches / sore throat / runny nose / sneezing / watery eyes

20 CHEWABLE TABLETS

Chew tablets completely before swallowing

Apple Cinnamon Flavor


* Please review the disclaimer below.