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  5. Label Information: Tylenol Extra Strength

FDA Label for Tylenol Extra Strength

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH CAPLET)
    2. PURPOSE
    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. PACKAGE LABELING:

Tylenol Extra Strength Product Label

The following document was submitted to the FDA by the labeler of this product Navajo Manufacturing Company Inc.. 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 Caplet)



Acetaminophen 500 mg


Purpose



Pain reliever/fever reducer


Uses



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


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.


Do Not Use



• 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 allergic to acetaminophen or any of the inactive ingredients in this product


Ask A Doctor Before Use If You Have



• liver disease


Ask A Doctor Or Pharmacist Before Use If You Are



taking the blood thinning drug warfarin


Stop Use And Ask A Doctor If



• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

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.



Overdose warning: 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 2 caplets every 6 hours while symptoms last

• do not take more than 6 caplets in 24 hours, unless directed by a doctor

• do not use for more than 10 days unless directed by a doctor

 children under 12 years ask a doctor


Other Information



• store between 20-25°C (68-77°F)

• see bottom of carton for lot number and expiration date
• do not use if pouch is opened


Inactive Ingredients



carnauba wax*, corn starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol*, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide
*contains one or more of these ingredients


Questions Or Comments?



call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)


* Please review the disclaimer below.