Extra Strength
1ddb8a2b-3081-3eda-e063-6294a90ab82b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen USP, 500 mg
Purpose
Pain reliever/fever reducer
Medication Information
Purpose
Pain reliever/fever reducer
Description
Acetaminophen USP, 500 mg
Uses
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
Directions
do not take more than directed (see overdose warning)
adults and children 12 years and over
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
children under 12 years
ask a doctor
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
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take
more than 4,000 mg of acetaminophen in 24 hours
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
Other Information
store between 20-25°C (68-77°F). See USP Controlled Room Temperature.
see bottom of the label for lot number and expiration date
Inactive Ingredients
hydroxypropyl methyl cellulose, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid
Questions Or Comments?
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
Principal Display Panel
Stop Use and Ask A Doctor If
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
These could be signs of a serious condition
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.
If Pregnant Or Breast Feeding,
ask a health professional before use
Active Ingredient (in Each Caplet)
Acetaminophen USP, 500 mg
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
Structured Label Content
Uses
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
Purpose
Pain reliever/fever reducer
Directions
do not take more than directed (see overdose warning)
adults and children 12 years and over
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
children under 12 years
ask a doctor
Do Not 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.
if you are allergic to acetaminophen or any of the inactive ingredients in this product
Liver Warning: (Liver warning:)
This product contains acetaminophen. Severe liver damage may occur if you take
more than 4,000 mg of acetaminophen in 24 hours
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
Other Information (Other information)
store between 20-25°C (68-77°F). See USP Controlled Room Temperature.
see bottom of the label for lot number and expiration date
Inactive Ingredients (Inactive ingredients)
hydroxypropyl methyl cellulose, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid
Questions Or Comments? (Questions or comments?)
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
Principal Display Panel (Principal display Panel)
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
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
These could be signs of a serious condition
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.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
ask a health professional before use
Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))
Acetaminophen USP, 500 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
liver disease
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
taking the blood thinning drug warfarin
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:49.051261 · Updated: 2026-03-14T23:11:40.308391