5004-rugby

5004-rugby
SPL v3
SPL
SPL Set ID c3df1652-96a8-6043-e053-2995a90a2d26
Route
oral
Published
Effective Date 2024-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
aspirin (250 mg) caffeine (65 mg) acetaminophen
Inactive Ingredients
polydextrose stearic acid microcrystalline cellulose povidone k30 hypromelloses talc titanium dioxide maltodextrin starch, corn silicon dioxide medium-chain triglycerides

Identifiers & Packaging

Pill Appearance
Imprint: 2793 Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-06-03

Description

Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug


Medication Information

Warnings and Precautions

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these

symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include: ■ hives ■ facial swelling ■ shock ■ asthma (wheezing)

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.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ with other drugs containing acetaminophen ■ more than 8 caplets in 24 hours, which is the maximum daily amount ■ 3 or more alcoholic drinks every day while

using this product

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ■ are age 60 or older ■ take more or for a longer time than directed ■ have had stomach ulcers or bleeding problems

■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] ■ have 3 or more alcoholic drinks every day while using this product

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Uses

■ temporarily relieves minor aches and pains due to:

■ headache

■ muscular aches

■ a cold

■ arthritis

■ toothache

■ premenstrual and menstrual cramps

Directions

■ do not use more than directed

■ drink a full glass of water with each dose

■ adults and children 12 years and over:

■ take 2 caplets every 6 hours

■ do not take more than 8 caplets in 24 hours

■ children under 12 years: ask a doctor

Other Information

■ Store in a dry place at 15° – 30°C (59° – 86°F)

■ use by expiration date on package

Description

Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Section 34088-5

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5

RETAIN THIS CARTON FOR COMPLETE PRODUCT INFORMATION

DISTRIBUTED BY: RUGBY® LABORATORIES

INDIANAPOLIS, IN 46268

(800) 616-2471 www.majorpharmaceuticals.com

†This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Excedrin®

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

■ you experience any of the following signs of stomach bleeding:

■ feel faint

■ have bloody or black stools

■ vomit blood

■ have stomach pain that does not get better

■ an allergic reaction occurs. Seek medical help right away.

■ ringing in the ears or loss of hearing occurs

■ pain gets worse or lasts for more than 10 days

■ fever gets worse or lasts for more than 3 days

■ painful area is red or swollen

■ any new symptoms appear.

These could be signs of a serious condition.

Section 50568-5

Ask a doctor or pharmacist before use if you are

■ taking a prescription drug for diabetes, gout, or arthritis

■ taking any other drug or are under a doctor’s care for any serious condition

Section 50569-3

Ask a doctor before use if

■ you have liver disease

■ stomach bleeding warning applies to you

■ you have a history of stomach problems, such as heartburn

■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you have asthma

■ you are taking a diuretic

Section 50570-1

Do not use

■ if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Section 51727-6

hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides

Section 51945-4

Rugby

Pain Reliever Plus

NDC 0536-1326-01

Compare to the active ingredients in Excedrin® Extra Strength Caplets†

Acetaminophen, Aspirin (NSAID)* and Caffeine

250mg/250mg/65mg

Pain Reliever/Pain Reliever Aid

NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

100 Caplets

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Section 55105-1

Purposes



Pain reliever

Pain reliever aid

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Questions Or Comments?

(800) 231-4670


Structured Label Content

Warnings and Precautions (34071-1)

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these

symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include: ■ hives ■ facial swelling ■ shock ■ asthma (wheezing)

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.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ with other drugs containing acetaminophen ■ more than 8 caplets in 24 hours, which is the maximum daily amount ■ 3 or more alcoholic drinks every day while

using this product

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ■ are age 60 or older ■ take more or for a longer time than directed ■ have had stomach ulcers or bleeding problems

■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] ■ have 3 or more alcoholic drinks every day while using this product

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Uses

■ temporarily relieves minor aches and pains due to:

■ headache

■ muscular aches

■ a cold

■ arthritis

■ toothache

■ premenstrual and menstrual cramps

Directions

■ do not use more than directed

■ drink a full glass of water with each dose

■ adults and children 12 years and over:

■ take 2 caplets every 6 hours

■ do not take more than 8 caplets in 24 hours

■ children under 12 years: ask a doctor

Other Information (Other information)

■ Store in a dry place at 15° – 30°C (59° – 86°F)

■ use by expiration date on package

Section 34088-5 (34088-5)

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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)

RETAIN THIS CARTON FOR COMPLETE PRODUCT INFORMATION

DISTRIBUTED BY: RUGBY® LABORATORIES

INDIANAPOLIS, IN 46268

(800) 616-2471 www.majorpharmaceuticals.com

†This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Excedrin®

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■ you experience any of the following signs of stomach bleeding:

■ feel faint

■ have bloody or black stools

■ vomit blood

■ have stomach pain that does not get better

■ an allergic reaction occurs. Seek medical help right away.

■ ringing in the ears or loss of hearing occurs

■ pain gets worse or lasts for more than 10 days

■ fever gets worse or lasts for more than 3 days

■ painful area is red or swollen

■ any new symptoms appear.

These could be signs of a serious condition.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

■ taking a prescription drug for diabetes, gout, or arthritis

■ taking any other drug or are under a doctor’s care for any serious condition

Section 50569-3 (50569-3)

Ask a doctor before use if

■ you have liver disease

■ stomach bleeding warning applies to you

■ you have a history of stomach problems, such as heartburn

■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you have asthma

■ you are taking a diuretic

Section 50570-1 (50570-1)

Do not use

■ if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Section 51727-6 (51727-6)

hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides

Section 51945-4 (51945-4)

Rugby

Pain Reliever Plus

NDC 0536-1326-01

Compare to the active ingredients in Excedrin® Extra Strength Caplets†

Acetaminophen, Aspirin (NSAID)* and Caffeine

250mg/250mg/65mg

Pain Reliever/Pain Reliever Aid

NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

100 Caplets

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Section 55105-1 (55105-1)

Purposes



Pain reliever

Pain reliever aid

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Questions Or Comments? (Questions or comments?)

(800) 231-4670


Advanced Ingredient Data


Raw Label Data

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