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.

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 55106-9

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

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

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

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.

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 55106-9 (55106-9)

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

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.


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