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.
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
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
Other Information
Store in a dry place at 15° - 30°C (59° - 86°F)
Description
Active Ingredient (in each tablet) Acetaminophen 500 mg
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
Drug Facts
Active Ingredient (in each tablet)
Acetaminophen 500 mg
Questions Or Comments?
Call (800) 616-2471
Structured Label Content
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.
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
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
Other Information
Store in a dry place at 15° - 30°C (59° - 86°F)
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
Drug Facts
Active Ingredient (in each tablet)
Acetaminophen 500 mg
Questions Or Comments? (Questions or comments?)
Call (800) 616-2471
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:06:02.312049 · Updated: 2026-03-14T23:08:30.723878