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 Hf Acquisition Co Llc, Dba Healthfirst. 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.
Otc - Active Ingredient
Active ingredient (in each tablet)
Acetaminophen 500 mg
Otc - Purpose
Pain reliever/fever reducer
Indications & Usage
Uses
For the temporary relief of minor aches and pains associated with
headache
muscular aches
minor arthritis pain
common cold
toothache
menstrual cramps
For the reduction of fever.
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
more than 8 tablets in 24 hours, which is the maximum daily amount
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
Otc - Stop Use
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.
for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor
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 using and ask a doctor if
symptoms do not improve
new symptoms occur
pain or fever persists or gets worse
redness or swelling is present
If pregnant or breast-feeding,ask a health professional before use.
Stop using and ask a doctor if
symptoms do not improve
new symptoms occur
pain or fever persists or gets worse
redness or swelling is present
If pregnant or breast-feeding,ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions
do not use more than directed
Adults and children: (12 years and older)Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.
Children under 12 years:Do not give to children under 12 years of age
Other Safety Information
Other information
store at room temperature 59°-86°F (15°-30°C)
tamper-evident sealed packets
do not use any opened or torn packets
Inactive Ingredient
Inactive ingredients
corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.
* may contain
Questions
Questions or comments?1-800-777-4908
Otc - Ask Doctor
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
How Supplied
51662-1666-2 2Pack
* Please review the disclaimer below.
