Acetaminophen Caplets 8409
7fae4caf-a8aa-442e-97ee-0465577bdb87
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each caplet) 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 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.
Indications and Usage
Uses
- temporarily relieves minor aches and pains due to:
• headache
• the common cold
• backache
• minor pain of arthritis
• toothache
• muscular aches
• premenstrual and menstrual cramps
- temporarily reduces fever
Dosage and Administration
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
Description
Active ingredient (in each caplet) Acetaminophen 500 mg
Section 42229-5
Other information
- SODIUM FREE
- store between 20-25°C (68-77°F) excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Section 50565-1
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Section 50566-9
Stop using and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or last more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Section 50568-5
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Section 50569-3
Ask a doctor before use if you have liver disease
Section 50570-1
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
Section 51727-6
Inactive ingredients
hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycloate*, stearic acid, titanium dioxide
*may contain this ingredient
Questions or comments? Call 1-877-290-4008
Section 53413-1
Manufactured by:
Time-Cap Labs, Inc
7 Michael Avenue
Farmingdale, NY 11735
341R 0922
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Purpose
Pain reliever/fever reducer
Section 55106-9
Active ingredient (in each caplet)
Acetaminophen 500 mg
Principal Display Panel Unit Dose
Principal Display Panel Bingo Card
Structured Label Content
Indications and Usage (34067-9)
Uses
- temporarily relieves minor aches and pains due to:
• headache
• the common cold
• backache
• minor pain of arthritis
• toothache
• muscular aches
• premenstrual and menstrual cramps
- temporarily reduces fever
Dosage and Administration (34068-7)
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
Warnings and Precautions (34071-1)
Warnings
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.
Section 42229-5 (42229-5)
Other information
- SODIUM FREE
- store between 20-25°C (68-77°F) excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Section 50565-1 (50565-1)
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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)
Stop using and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or last more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Section 50569-3 (50569-3)
Ask a doctor before use if you have liver disease
Section 50570-1 (50570-1)
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
Section 51727-6 (51727-6)
Inactive ingredients
hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycloate*, stearic acid, titanium dioxide
*may contain this ingredient
Questions or comments? Call 1-877-290-4008
Section 53413-1 (53413-1)
Manufactured by:
Time-Cap Labs, Inc
7 Michael Avenue
Farmingdale, NY 11735
341R 0922
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Purpose
Pain reliever/fever reducer
Section 55106-9 (55106-9)
Active ingredient (in each caplet)
Acetaminophen 500 mg
Principal Display Panel Unit Dose (PRINCIPAL DISPLAY PANEL - UNIT DOSE)
Principal Display Panel Bingo Card (PRINCIPAL DISPLAY PANEL - BINGO CARD)
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:16.140614 · Updated: 2026-03-14T23:10:31.490874