package/label principal display panel

package/label principal display panel
SPL v3
SPL
SPL Set ID 7b21e737-25f9-49a1-9517-16f22e76f0fc
Route
oral
Published
Effective Date 2024-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

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 4,000 mg of acetaminophen in 24 hours • 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 heart beat.

Active Ingredient

Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Indications and Usage

• temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps

Dosage and Administration

• 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 geltabs every 6 hours; not more than 8 geltabs in 24 hours • children under 12 years: ask a doctor

Description

Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Section 50565-1

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 50566-9

• 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

taking • a prescription drug for diabetes, gout, or arthritis • any other drug, or are under a doctor’s care for any serious condition

Section 50569-3

• 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

• 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

black iron oxide, carnauba wax, crospovidone, D & C yellow #10 aluminum lake, FD & C blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltitol solution, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polyvinyl acetate phthalate, povidone, pregelatinized starch, propylene glycol, stearic acid, titanium dioxide

Section 51945-4

Walgreens WALGREENS PHARMACIST RECOMMENDED Compare to the active ingredients in Excedrin® Extra Strength Headache Relief ACETAMINOPHEN / ASPIRIN (NSAID) / CAFFEINE PAIN RELIEVER / PAIN RELIEVER AID Extra Strength 20 GELTABS SEE NEW WARNING ACTUAL SIZE

Section 53413-1

1-800-719-9260

Section 53414-9

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

Pain reliever Pain reliever aid

Section 60561-8

• store at 20° -25°C (68° -77°F) • close cap tightly after use • read all product information before using. Keep this box for important information.


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: 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 4,000 mg of acetaminophen in 24 hours • 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 heart beat.

Active Ingredient (55106-9)

Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Indications and Usage (34067-9)

• temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps

Dosage and Administration (34068-7)

• 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 geltabs every 6 hours; not more than 8 geltabs in 24 hours • children under 12 years: ask a doctor

Section 50565-1 (50565-1)

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 50566-9 (50566-9)

• 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)

taking • a prescription drug for diabetes, gout, or arthritis • any other drug, or are under a doctor’s care for any serious condition

Section 50569-3 (50569-3)

• 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)

• 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)

black iron oxide, carnauba wax, crospovidone, D & C yellow #10 aluminum lake, FD & C blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltitol solution, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polyvinyl acetate phthalate, povidone, pregelatinized starch, propylene glycol, stearic acid, titanium dioxide

Section 51945-4 (51945-4)

Walgreens WALGREENS PHARMACIST RECOMMENDED Compare to the active ingredients in Excedrin® Extra Strength Headache Relief ACETAMINOPHEN / ASPIRIN (NSAID) / CAFFEINE PAIN RELIEVER / PAIN RELIEVER AID Extra Strength 20 GELTABS SEE NEW WARNING ACTUAL SIZE

Section 53413-1 (53413-1)

1-800-719-9260

Section 53414-9 (53414-9)

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)

Pain reliever Pain reliever aid

Section 60561-8 (60561-8)

• store at 20° -25°C (68° -77°F) • close cap tightly after use • read all product information before using. Keep this box for important information.


Raw Label Data

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