5427-rugby

5427-rugby
SPL v3
SPL
SPL Set ID 76f10ee2-1d6a-097c-e053-2991aa0af526
Route
ORAL
Published
Effective Date 2024-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Corn Povidone K30 Stearic Acid Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: 54;27 Shape: round Color: white Size: 12 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-10-01 Until 2025-11-30

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

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