Walgreens Headache Relief Geltabs

Walgreens Headache Relief Geltabs
SPL v5
SPL
SPL Set ID 98bb28ed-d146-ca3d-e053-2a95a90a9eaf
Route
ORAL
Published
Effective Date 2024-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Aspirin (65 mg) Caffeine
Inactive Ingredients
Starch, Corn D&c Yellow No. 10 Aluminum Lake Ethylcellulose, Unspecified Fd&c Blue No. 1 Aluminum Lake Fd&c Red No. 40 Aluminum Lake Gelatin, Unspecified Glycerin Hypromellose, Unspecified Isopropyl Alcohol Lactose Monohydrate Light Mineral Oil Microcrystalline Cellulose Starch, Potato Water Povidone K30 Sorbitol Sorbitan Stearic Acid Talc Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: S77 Shape: round Color: green Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-24

Description

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

Purpose

Pain reliever Pain reliever Pain reliever aid


Medication Information

Purpose

Pain reliever Pain reliever Pain reliever aid

Description

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

Uses

Temporarily relieves minor aches and pains due to:

• headache • a cold • arthritis • muscular aches • toothache • premenstrual and menstrual cramps

Section 42229-5

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

Extra Strength

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

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

Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands.

††This product is not manufactured or distributed by GSK Consumer Healthcare SARL, owner of the registered trademark Excedrin®.

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com 1-800-925-4733

©2021 Walgreen Co.

PRODUCT OF UNITED ARAB EMIRATES

Section 50565-1

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Purposes

Pain reliever

Pain reliever

Pain reliever aid

Warnings

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 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 geltabs 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 occasional rapid heartbeat.

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.

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

Ask a doctor or pharmacist before use if you are taking

• a prescription drug for diabetes, gout, or arthritis

• any other drug, or are under a doctor's care for any serious condition

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.

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.

Packaging

Directions

• do not use more than directed (see overdose warning)

• drink a full glass of water with each dose

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

• children under 12 years: ask a doctor

Other Information

• store at room temperature between 20-25°C(68-77°F)

• avoid excessive heat, cold and humidity

Inactive Ingredients

corn starch, D&C yellow #10 aluminum lake, edible black ink, ethyl cellulose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, isopropyl alcohol, lactose monohydrate, light mineral oil, microcrystalline cellulose, pregelatinized potato starch, purified water, pvpk-30, sorbitol sorbitan solution, stearic acid, talc, titanium dioxide, triacetin

Questions Or Comments?

1-888-577-8033 Monday-Friday 8am-4pm EST

Active Ingredients (in Each Geltab)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug


Structured Label Content

Uses

Temporarily relieves minor aches and pains due to:

• headache • a cold • arthritis • muscular aches • toothache • premenstrual and menstrual cramps

Section 42229-5 (42229-5)

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

Extra Strength

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

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

Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands.

††This product is not manufactured or distributed by GSK Consumer Healthcare SARL, owner of the registered trademark Excedrin®.

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com 1-800-925-4733

©2021 Walgreen Co.

PRODUCT OF UNITED ARAB EMIRATES

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Purposes

Pain reliever

Pain reliever

Pain reliever aid

Warnings

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 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 geltabs 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 occasional rapid heartbeat.

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.

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

Ask a doctor or pharmacist before use if you are taking

• a prescription drug for diabetes, gout, or arthritis

• any other drug, or are under a doctor's care for any serious condition

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.

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.

Packaging

Directions

• do not use more than directed (see overdose warning)

• drink a full glass of water with each dose

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

• children under 12 years: ask a doctor

Other Information (Other information)

• store at room temperature between 20-25°C(68-77°F)

• avoid excessive heat, cold and humidity

Inactive Ingredients (Inactive ingredients)

corn starch, D&C yellow #10 aluminum lake, edible black ink, ethyl cellulose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, isopropyl alcohol, lactose monohydrate, light mineral oil, microcrystalline cellulose, pregelatinized potato starch, purified water, pvpk-30, sorbitol sorbitan solution, stearic acid, talc, titanium dioxide, triacetin

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday-Friday 8am-4pm EST

Active Ingredients (in Each Geltab) (Active ingredients (in each geltab))

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)