5427-major
9af5ccc8-aac0-4339-a9f6-58fdc9b91c57
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
-
•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
SAVE CARTON FOR COMPLETE DRUG FACTS
Do not use if carton is open or if imprinted safety seal under cap is broken or missing.
Distributed By:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Repackaged By:
Proficient Rx LP
Thousand Oaks, CA 91320
*This product is not manufactured or distributed by McNeil Consumer Healthcare, 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 51945-4
See New Warnings Information and Directions
Acetaminophen Extra Strength Tablets
Aspirin Free
Strong Pain and Fever Relief
Compare to active ingredient in Extra Strength Tylenol®*
50 tablets
500mg each
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 (800) 616-2471
Structured Label Content
Uses
Temporarily reduces fever and relieves minor aches and pains due to:
-
•headache
-
•muscular aches
-
•backache
-
•minor pain of arthritis
-
•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)
SAVE CARTON FOR COMPLETE DRUG FACTS
Do not use if carton is open or if imprinted safety seal under cap is broken or missing.
Distributed By:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Repackaged By:
Proficient Rx LP
Thousand Oaks, CA 91320
*This product is not manufactured or distributed by McNeil Consumer Healthcare, 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 51945-4 (51945-4)
See New Warnings Information and Directions
Acetaminophen Extra Strength Tablets
Aspirin Free
Strong Pain and Fever Relief
Compare to active ingredient in Extra Strength Tylenol®*
50 tablets
500mg each
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 (800) 616-2471
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:02.312049 · Updated: 2026-03-14T23:08:30.723878