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 Strive Pharmaceuticals 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.
Otc - Active Ingredient
Acetaminophen 500mg
Inactive Ingredient
hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Dosage & Administration
- do not take more than directed.SEE OVERDOSE WARNING
- 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
adults and children 12 years of age and over | |
children under 12 years of age | ask a doctor |
Indications & Usage
*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 fever
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4000mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
- with any other drug containing acetaminophen (prescription or non prescription). 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
- liver disease
- 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
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
Ask a doctor before use if you have
Ask a doctor or a pharmacist before use if
you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
These could be signs of a serious comdition
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. Prompt medical attention is critical for adults as well as children even if do not notice any signs or symptoms.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Overdose Warning: 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.
Otc - Purpose
Pain reliever / Fever reducer
Other Safety Information
- store at room temperature between 20 °C - 25 °C (68 °F - 77 °F)
- avoid excessive heat, cold and humidity
- close cap tightly after use
Package Label.Principal Display Panel
* Please review the disclaimer below.