5427
9efcce86-dd57-4ea2-ad31-d2038eb61bf1
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
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.
Description
Active Ingredient (in each tablet) Acetaminophen 500 mg
Uses
Temporarily reduces fever and relieves minor aches and pains due to:
-
•headache
-
•muscular aches
-
•backache
-
•minor pain of arthritis
-
•the common cold
-
•toothache
-
•premenstrual and menstrual cramps
Section 34088-5
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.
Section 42229-5
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
|
Re-order No. 700923 |
M-29 |
Rev. 09/23 |
R52341 |
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Overbagged with 10 tablets per bag, NDC 55154-7897-0
WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.
Distributed By:
Cardinal Health
Dublin, OH 43017
L548143-10624 / L5488143-20624
*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol®.
Section 50565-1
Keep out of reach of children.
Section 50566-9
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.
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
-
•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
Povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Purpose
Pain reliever/ Fever reducer
Directions
-
•do not take more than directed (see overdose warning)
adults and children 12 years and over:
• take 2 tablets every 6 hours while symptoms last
• do not take more than 6 tablets in 24 hours, unless directed by a doctor
• do not take for more than 10 days unless directed by a doctor
children under 12 years: ask a doctor
Drug Facts
Active Ingredient (in each tablet)
Acetaminophen 500 mg
Other Information
store in a dry place at 15° – 30°C (59° – 86°F).
Questions Or Comments?
Call 1-800-231-4670
Principal Display Panel
NDC 55154-7897-0
ACETAMINOPHEN
EXTRA STRENGTH TABLETS
500 mg
10 TABLETS
Structured Label Content
Uses
Temporarily reduces fever and relieves minor aches and pains due to:
-
•headache
-
•muscular aches
-
•backache
-
•minor pain of arthritis
-
•the common cold
-
•toothache
-
•premenstrual and menstrual cramps
Warnings and Precautions (34071-1)
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 34088-5 (34088-5)
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.
Section 42229-5 (42229-5)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
|
Re-order No. 700923 |
M-29 |
Rev. 09/23 |
R52341 |
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Overbagged with 10 tablets per bag, NDC 55154-7897-0
WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.
Distributed By:
Cardinal Health
Dublin, OH 43017
L548143-10624 / L5488143-20624
*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol®.
Section 50565-1 (50565-1)
Keep out of reach of children.
Section 50566-9 (50566-9)
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.
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)
-
•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)
Povidone, pregelatinized starch, sodium starch glycolate, stearic acid
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
Directions
-
•do not take more than directed (see overdose warning)
adults and children 12 years and over:
• take 2 tablets every 6 hours while symptoms last
• do not take more than 6 tablets in 24 hours, unless directed by a doctor
• do not take for more than 10 days unless directed by a doctor
children under 12 years: ask a doctor
Drug Facts
Active Ingredient (in each tablet)
Acetaminophen 500 mg
Other Information
store in a dry place at 15° – 30°C (59° – 86°F).
Questions Or Comments? (Questions or comments?)
Call 1-800-231-4670
Principal Display Panel
NDC 55154-7897-0
ACETAMINOPHEN
EXTRA STRENGTH TABLETS
500 mg
10 TABLETS
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:08.612805 · Updated: 2026-03-14T23:10:23.192014