FDA Label for Acetaminophen
View Indications, Usage & Precautions
Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. 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)/Purpose
Acetaminophen 325mg....................Analgesic/Antipyretic
Uses
temporary relief of minor aches and pains associated with
• common cold• headache• toothache• muscular aches• backache• arthritis• menstrual cramps• and reduction of fever
Purpose
Analgesic/Antipyretic
Alcohol Warning:
If you consume 3 or more alcoholic drinks every day, ask
your doctor whether you should take acetaminophen or other pain relievers/fever
reducers. Acetaminophen may cause liver damage.
Do Not Use
with any other products containing acetaminophen.
Stop Use And Ask A Doctor If
• symptoms do not improve• pain gets worse or lasts for more than 10 days• fever gets worse or lasts for more than 3 days• new symptoms occur• redness or swelling is present• a rare sensitivity reaction occurs
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage.
Dosage & Administration
Directions
Adults and children 12 years of age and older
• take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.• Take 1 tablet every 4 to 6 hours as needed. Do not take more than 5 tablets in 24 hours.• Do not use this regular strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.
Children 6-11 years of age
Children under 6 years of age
Storage And Handling
Other Information
• store at room temperature 59°-86°F (15°-30°C).
Inactive Ingredient
Inactive Ingredients corn starch, pregelatinized starch, stearic acid.
May contain povidone and sodium starch glycolates.
How Supplied
Product: 50090-2783
NDC: 50090-2783-0 1 TABLET in a BLISTER PACK / 30 in a BOX, UNIT-DOSE
NDC: 50090-2783-1 30 TABLET in a BLISTER PACK / 25 in a BOX, UNIT-DOSE
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