SPL v2
SPL
SPL Set ID 40cd1a7a-e941-4503-8fe4-e939bd0d9d72
Route
ORAL
Published
Effective Date 2025-02-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Aspirin (65 mg) Caffeine
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Starch, Corn Povidone K30 Sodium Starch Glycolate Type A Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: HH6 Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-01

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 & menstrual cramps

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 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 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 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 aa prescription drug for diabetes, gout, or arthritis

• taking 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 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.

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; not more than 8 caplets in 24 hours

•  children under 12 years:ask a doctor

Questions?

call toll-free 1-844-912-4012

Other Information
  • store at 20°-25°C(68°-77°F)
  • close cap tightly after use
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, PVPK-30, sodium starch glycolate, stearic acid, talc, titanium dioxide.

Principal Display Panel 100 Count

NDC 37835-531-01

Compare to the active ingredients in Excedrin® Extra Strength*

Extra Strength

Acetaminophen, Aspirin (NSAID)**, and Caffeine

Pain Reliever/ Pain Reliever Aid

100 Caplets

*This product is not manufactured or distributed by the owner of the registered trademark Excedrin ®Extra Strength.

Distributed by:

BI-MART

Eugene, OR 97402

Principal Display Panel 250 Count

NDC 37835-531-25

Compare to the active ingredients in Excedrin® Extra Strength*

Extra Strength

Acetaminophen, Aspirin (NSAID)**, and Caffeine

Pain Reliever/ Pain Reliever Aid

250 Caplets

*This product is not manufactured or distributed by the owner of the registered trademark Excedrin ®Extra Strength.

Distributed by:

BI-MART

Eugene, OR 97402

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 & menstrual cramps

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 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 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 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 aa prescription drug for diabetes, gout, or arthritis

• taking 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 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.

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; not more than 8 caplets in 24 hours

•  children under 12 years:ask a doctor

Questions?

call toll-free 1-844-912-4012

Other Information (Other information)
  • store at 20°-25°C(68°-77°F)
  • close cap tightly after use
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, PVPK-30, sodium starch glycolate, stearic acid, talc, titanium dioxide.

Principal Display Panel 100 Count (PRINCIPAL DISPLAY PANEL-100 Count)

NDC 37835-531-01

Compare to the active ingredients in Excedrin® Extra Strength*

Extra Strength

Acetaminophen, Aspirin (NSAID)**, and Caffeine

Pain Reliever/ Pain Reliever Aid

100 Caplets

*This product is not manufactured or distributed by the owner of the registered trademark Excedrin ®Extra Strength.

Distributed by:

BI-MART

Eugene, OR 97402

Principal Display Panel 250 Count (PRINCIPAL DISPLAY PANEL-250 Count)

NDC 37835-531-25

Compare to the active ingredients in Excedrin® Extra Strength*

Extra Strength

Acetaminophen, Aspirin (NSAID)**, and Caffeine

Pain Reliever/ Pain Reliever Aid

250 Caplets

*This product is not manufactured or distributed by the owner of the registered trademark Excedrin ®Extra Strength.

Distributed by:

BI-MART

Eugene, OR 97402

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)