FDA Label for Acetaminophen 500mg Caffeine 65mg
View Indications, Usage & Precautions
Acetaminophen 500mg Caffeine 65mg 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; Caffeine 65mg
Inactive Ingredient
colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #2, FD&C yellow #6, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, pregalatinized starch, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide
Dosage & Administration
- take with a full glass of water
- do not take more than directed
- do not take more than 6 caplets in 24 hours
adults and children 12 years of age and over | take 2 caplets every 6 hours, not more than 6 caplets in 24 hours |
children under 12 years of age | ask a doctor |
Indications & Usage
*temporarily relieves minor aches and pains due to:
- headache
- muscular aches
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 caplets in 24 hours, which is the maimum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
- if you are allergic to acetaminophen
- 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
- liver disease
- pain gets worse or lasts more than 10 days
- new symptoms occur
- painful area is red or swollen
Allergy alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
if a skin reaction occurs, stop use and seek medical help right away
Caffeine warning:
The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods or beverages while takingthis product because too much caffeine may cause nervousness, irritability, sleeplessness, and occassionally rapis heart beat.
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 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 - 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 ; Pain reliever aid
Other Safety Information
- store at room temperature between 20 °C - 25 °C (68 °F - 77 °F)
Package Label.Principal Display Panel
* Please review the disclaimer below.