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.
Drug Facts
Active ingredient (in each tablet)
Acetaminophen 325 mg
Otc - Purpose
Purpose
Pain reliever/ Fever reducer
Uses
Temporarily reduces fever and relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain of arthritis
- common cold
- toothache
- premenstrual and menstrual cramps
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
- skin reddening
- blisters
- rash
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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
Otc - Ask Doctor
Ask a doctor before use if you have liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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. This Unit Dose package is not child
resistant and is Intended for Institutional Use Only.
Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years and over:
- take 2 tablets every 4 to 6 hours while symptoms last
- do not take more than 10 tablets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
- children 6 years to under 12 years
- take 1 tablet every 4 to 6 hours while symptoms last
- do not take more than 5 tablets in 24 hours
- do not use for more than 5 days unless directed by a doctor
- children under 12 years: ask a doctor
Other Information
store at room temperature
Inactive Ingredient
Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.
Questions Or Comments?
(800) 616-2471
Other
Tamper Evident: Do not use if sealed blister units are broken or damaged.
Distributed By: MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152
How Supplied
Product: 50090-4273
NDC: 50090-4273-0 1 TABLET in a BLISTER PACK / 30 in a BOX, UNIT-DOSE
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