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  5. Label Information: Tylo Extra (acetaminophen)

FDA Label for Tylo Extra (acetaminophen)

View Indications, Usage & Precautions

Table of Contents

    1. TYLO EXTRA 1000 MG
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. OVERDOSE WARNING
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS OR COMMENTS?

Tylo Extra (acetaminophen) Product Label

The following document was submitted to the FDA by the labeler of this product America Medic & Science, 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.

Tylo Extra 1000 Mg



Drug Facts


Active Ingredient



Acetaminophen 1000 mg


Purpose



Pain reliever/fever reducer


Uses



  • temporarily relieves minor aches and pains due to:
  • headache
  • backache
  • minor pain of arthritis
  • temporarily reduces fever
  • the common cold
  • toothache
  • menstrual cramps
  • muscular aches

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.

Do Not Use



  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to acetaminophen or any of the inactive ingredients in this product.

Overdose Warning



Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



do not take more than directed (see overdose warning).

Adults and children 12 years and over:

  • take 1 caplet every 6 to 8 hours
  • Do not take more than 4 caplets of this product in 24 hours.

    • Children under 12 years:

    • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other Information



  • store between 20-25°C (68-77°F)
  • see end panel for lot number and expiration date

Inactive Ingredients



  • Carnauba wax, hypromellose, polyethylene glycol, propylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments?



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