35478de8-50d0-5d0a-e063-6294a90a88ba
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each tablet) Acetaminophen 500 mg
Medication Information
Warnings and Precautions
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
Indications and 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.
Dosage and 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
Dosage Forms and Strengths
51662-1666-2 2Pack
Description
Active ingredient (in each tablet) Acetaminophen 500 mg
Section 50565-1
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.
Section 50566-9
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.
Section 50569-3
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
Section 51727-6
Inactive ingredients
corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.
* may contain
Section 51945-4
Section 55105-1
Pain reliever/fever reducer
Section 55106-9
Active ingredient (in each tablet)
Acetaminophen 500 mg
Section 60561-8
Other information
store at room temperature 59º-86ºF (15º-30ºC)
tamper-evident sealed packets
do not use any opened or torn packets
Questions
Questions or comments?1-800-777-4908
Structured Label Content
Indications and Usage (34067-9)
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.
Dosage and Administration (34068-7)
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
Dosage Forms and Strengths (34069-5)
51662-1666-2 2Pack
Warnings and Precautions (34071-1)
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
Section 50565-1 (50565-1)
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.
Section 50566-9 (50566-9)
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.
Section 50569-3 (50569-3)
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
Section 51727-6 (51727-6)
Inactive ingredients
corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.
* may contain
Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Pain reliever/fever reducer
Section 55106-9 (55106-9)
Active ingredient (in each tablet)
Acetaminophen 500 mg
Section 60561-8 (60561-8)
Other information
store at room temperature 59º-86ºF (15º-30ºC)
tamper-evident sealed packets
do not use any opened or torn packets
Questions (QUESTIONS)
Questions or comments?1-800-777-4908
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:08.555715 · Updated: 2026-03-14T23:08:46.104923