5427-rugby
76f10ee2-1d6a-097c-e053-2991aa0af526
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each tablet) Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
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.
Purpose
Pain reliever/fever reducer
Description
Active ingredient (in each tablet) Acetaminophen 500 mg
Uses
Temporarily reduces fever and relieves minor aches and pains caused by
• headache
• muscular aches
• the common cold
• toothache
• backache
• minor pain of arthritis
• premenstrual and menstrual cramps
Section 42229-5
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Rugby Laboratories is not affiliated with the owner of the registered trademark Tylenol®.
Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268
Questions or comments?
Call (800) 616-2471
www.majorpharmaceuticals.com
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 51727-6
Povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Section 51945-4
Rugby
COMPARE TO THE ACTIVE INGREDIENT IN EXTRA STRENGTH TYLENOL®*
NDC 0536-1172-01
Extra Strength Acetaminophen
500mg each
Pain Reliever/Fever Reducer
Aspirin Free
100 Tablets
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
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
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
Drug Facts
Active ingredient (in each tablet)
Acetaminophen 500 mg
Other Information
store in a dry place at 15° – 30°C (59° – 86°F).
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.
Questions Or Comments?
Call 1-800-231-4670
Structured Label Content
Uses
Temporarily reduces fever and relieves minor aches and pains caused by
• headache
• muscular aches
• the common cold
• toothache
• backache
• minor pain of arthritis
• 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 42229-5 (42229-5)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Rugby Laboratories is not affiliated with the owner of the registered trademark Tylenol®.
Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268
Questions or comments?
Call (800) 616-2471
www.majorpharmaceuticals.com
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 51727-6 (51727-6)
Povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Section 51945-4 (51945-4)
Rugby
COMPARE TO THE ACTIVE INGREDIENT IN EXTRA STRENGTH TYLENOL®*
NDC 0536-1172-01
Extra Strength Acetaminophen
500mg each
Pain Reliever/Fever Reducer
Aspirin Free
100 Tablets
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
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
Do Not Use (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
Drug Facts
Active ingredient (in each tablet)
Acetaminophen 500 mg
Other Information (Other information)
store in a dry place at 15° – 30°C (59° – 86°F).
Overdose Warning: (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.
Questions Or Comments? (Questions or comments?)
Call 1-800-231-4670
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:40.705336 · Updated: 2026-03-14T23:02:21.986500