Walmart Acetaminophen 250 Mg, Aspirin 250 Mg, Caffeine 65 Mg Tablets

Walmart Acetaminophen 250 Mg, Aspirin 250 Mg, Caffeine 65 Mg Tablets
SPL v3
SPL
SPL Set ID 1557bd9b-3e7c-4769-e063-6394a90a9d91
Route
ORAL
Published
Effective Date 2024-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Caffeine (65 mg) Aspirin
Inactive Ingredients
Carnauba Wax Microcrystalline Cellulose Titanium Dioxide Stearic Acid Povidone Starch, Corn Sodium Starch Glycolate Type A Corn Mineral Oil Hypromelloses Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL370 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-30

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: 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.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

• hives

• facial swelling

• asthma (wheezing)

• shock

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 8 caplets in 24 hours, which is the maximum daily amount

• with other drugs containing acetaminophen

• 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

• 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

• take more or for a longer time than directed

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.

Indications and Usage

Uses

  • temporarily relieves minor aches and pains due to:

-headache

-a cold

-arthritis

-muscular aches

-toothache

-premenstrual and menstrual cramps

Dosage and Administration

Directions

• do ​not use more than directed

• drink a full glass of water with each dose

• adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours

• children under 12 years: ask a doctor

Description

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

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

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

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

-feel faint

-vomit blood

-have bloody or black stools

-have stomach pain that does not get better

• ringing in the ears or loss of hearing occurs

• painful area is red or swollen

• pain gets worse or lasts for more than 10 days

• fever gets worse or lasts for more than 3 days

• any new symptoms occur

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 are taking a diuretic

• you have asthma

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

Inactive ingredients

carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxid

Section 51945-4

Section 53413-1

Questions or comments? Call 1-888-287-1915

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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

Pain reliever aid

Section 55106-9

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Section 60561-8

Other information

• store at 20°- 25°C (68°- 77°F); excursions permitted between 15°-30°C (59°-86°F)

• use by expiration date on package


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves minor aches and pains due to:

-headache

-a cold

-arthritis

-muscular aches

-toothache

-premenstrual and menstrual cramps

Dosage and Administration (34068-7)

Directions

• do ​not use more than directed

• drink a full glass of water with each dose

• adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours

• children under 12 years: ask a doctor

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: 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.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

• hives

• facial swelling

• asthma (wheezing)

• shock

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 8 caplets in 24 hours, which is the maximum daily amount

• with other drugs containing acetaminophen

• 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

• 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

• take more or for a longer time than directed

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

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

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

-feel faint

-vomit blood

-have bloody or black stools

-have stomach pain that does not get better

• ringing in the ears or loss of hearing occurs

• painful area is red or swollen

• pain gets worse or lasts for more than 10 days

• fever gets worse or lasts for more than 3 days

• any new symptoms occur

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 are taking a diuretic

• you have asthma

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)

Inactive ingredients

carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxid

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-888-287-1915

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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

Pain reliever aid

Section 55106-9 (55106-9)

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Section 60561-8 (60561-8)

Other information

• store at 20°- 25°C (68°- 77°F); excursions permitted between 15°-30°C (59°-86°F)

• use by expiration date on package


Advanced Ingredient Data


Raw Label Data

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