SPL v1
SPL
SPL Set ID 40e2b5ea-a8ea-f1c6-e063-6394a90a1e6f
Route
ORAL
Published
Effective Date 2025-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (500 mg) Caffeine (32.5 mg)
Inactive Ingredients
Sodium Lauryl Sulfate Hypromellose, Unspecified Maltodextrin Microcrystalline Cellulose Starch, Corn Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: 44;413 Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-10

Description

Active ingredients (in each caplet) ​Aspirin (NSAID)* 500 mg Caffeine 32.5 mg *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever Pain reliever aid


Medication Information

Purpose

Pain reliever

Pain reliever aid

Description

Active ingredients (in each caplet) ​Aspirin (NSAID)* 500 mg Caffeine 32.5 mg *nonsteroidal anti-inflammatory drug

Uses

for the temporary relief of

■ backache pain

■ muscle aches and pains

■ minor aches and pains of arthritis

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.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug for

■ gout

■ diabetes

■ arthritis

Section 51945-4

AEROTAB

Pain Reliever

Aspirin (NSAID) 500 mg, Caffeine 32.5 mg

Fast Acting Formula

Relieves aches and pains

Contains Caffeine

50 | 2 per packet

Section 53413-1

Questions or comments? 1-845-618-7037

(Monday through Friday 9AM - 5PM EST).

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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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:

Aspirin may cause a severe allergic reaction which may include:

■ hives

■ shock

■ facial swelling

■ asthma (wheezing)

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

■ take more or for a longer time than directed

■ take a blood thinning (anticoagulant) or steroid drug

■ are age 60 or older

■ have 3 or more alcohol drinks every day while using this product

■ have had stomach ulcers or bleeding problems

■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

Directions

■ drink a full glass of water with each dose

Adults and children (12 years and over): take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours

Children under 12 years: do not use unless directed by a doctor

Do Not Use

■ if you are allergic to aspirin or any other pain reliever/fever reducer.

■ if you have ever had an allergic reaction to this product or any of its ingredients

Drug Facts

Active ingredients (in each caplet)

​Aspirin (NSAID)* 500 mg

Caffeine 32.5 mg

*nonsteroidal anti-inflammatory drug

Other Information

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

■ tamper evident sealed packets

■ do not use any opened or torn packets

Inactive Ingredients

corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

Ask A Doctor Before Use If

■ stomach bleeding warning applies to you

■ you have a history of stomach problems, such as heartburn

■ you have asthma

■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you are taking a diuretic

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: ■ vomit blood ■ have bloody or black stools ■ feel faint ■ have stomach pain that does not get better

■ ringing in the ears or a loss of hearing occurs

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ redness or swelling is present

■ new symptoms occur

These could be signs of a serious condition.


Structured Label Content

Uses

for the temporary relief of

■ backache pain

■ muscle aches and pains

■ minor aches and pains of arthritis

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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug for

■ gout

■ diabetes

■ arthritis

Section 51945-4 (51945-4)

AEROTAB

Pain Reliever

Aspirin (NSAID) 500 mg, Caffeine 32.5 mg

Fast Acting Formula

Relieves aches and pains

Contains Caffeine

50 | 2 per packet

Section 53413-1 (53413-1)

Questions or comments? 1-845-618-7037

(Monday through Friday 9AM - 5PM EST).

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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Purpose

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:

Aspirin may cause a severe allergic reaction which may include:

■ hives

■ shock

■ facial swelling

■ asthma (wheezing)

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

■ take more or for a longer time than directed

■ take a blood thinning (anticoagulant) or steroid drug

■ are age 60 or older

■ have 3 or more alcohol drinks every day while using this product

■ have had stomach ulcers or bleeding problems

■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

Directions

■ drink a full glass of water with each dose

Adults and children (12 years and over): take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours

Children under 12 years: do not use unless directed by a doctor

Do Not Use (Do not use)

■ if you are allergic to aspirin or any other pain reliever/fever reducer.

■ if you have ever had an allergic reaction to this product or any of its ingredients

Drug Facts

Active ingredients (in each caplet)

​Aspirin (NSAID)* 500 mg

Caffeine 32.5 mg

*nonsteroidal anti-inflammatory drug

Other Information (Other information)

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

■ tamper evident sealed packets

■ do not use any opened or torn packets

Inactive Ingredients (Inactive ingredients)

corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

Ask A Doctor Before Use If (Ask a doctor before use if)

■ stomach bleeding warning applies to you

■ you have a history of stomach problems, such as heartburn

■ you have asthma

■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you are taking a diuretic

Stop Use and Ask A Doctor If (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: ■ vomit blood ■ have bloody or black stools ■ feel faint ■ have stomach pain that does not get better

■ ringing in the ears or a loss of hearing occurs

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ redness or swelling is present

■ new symptoms occur

These could be signs of a serious condition.


Advanced Ingredient Data


Raw Label Data

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