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  5. Label Information: Acetaminophen 325mg

FDA Label for Acetaminophen 325mg

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. PRODUCT LABEL

Acetaminophen 325mg Product Label

The following document was submitted to the FDA by the labeler of this product Pharmaceutica North America, 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 Ingredient(In Each Tablet)



Acetaminophen 325mg


Purpose



Pain reliever/fever reducer


Uses



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


Warnings



Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children.
Severe liver damage may occur if
• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours, which  is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 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 the user has liver disease
Ask a doctor or pharmacist before use if the user istaking the blood thinning drug warfarin
Stop use and ask a doctor if
• pain gets worse or lasts more than 10 days in adults
• pain gets worse or lasts more than 5 days in children under 12 years
• 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 the reach of children.
Overdose warning:
In the 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 a 2 tablets, every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless direact by a doctor
  • do not use more than 10 days unless directed by a doctor
 children 6 to under 12 years
  • take a one tablet, every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use more than 5 days unless directed by a doctor
 children under 6 years    ask a doctor


Other Information



• store between 20-25°C (68-77°F)


Inactive Ingredients



povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid


Product Label



image description - image 85

image description - image 85


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