Bayer ®

Bayer ®
SPL v10
SPL
SPL Set ID f1fecbb0-5b55-fe8f-e053-2995a90a0977
Route
ORAL
Published
Effective Date 2023-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (65 mg) Aspirin (650 mg)
Inactive Ingredients
Sucralose Anhydrous Citric Acid Mannitol Neotame Monosodium Citrate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-13

Description

Drug Facts

Purpose

Pain reliever/fever reducer Pain reliever aid


Medication Information

Purpose

Pain reliever/fever reducer

Pain reliever aid

Description

Drug Facts

Uses

temporarily relieves minor aches and pains due to: • headache • muscle pain • backache • menstrual cramps • minor pain of arthritis • temporarily reduces feve

Section 42229-5

Drug Facts

Section 51945-4

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 • facial swelling • asthma (wheezing) • shock 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

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 Ask a doctor before use if ● 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 ● gout ● diabetes ● arthritis 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 ● 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 ● ringing in the ears or a loss of hearing occurs 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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over: take contents of 1 powder pack every 6 hours. Dissolve powder on tongue, followed by a full glass of water. Do not exceed 4 powder packs in 24 hours. ● children under 12 years: consult a doctor

Other Information

● phenylketonurics: contains phenylalanine 0.0017 mg per powder pack ● save carton for full directions and warnings ● Store between 20°- 25 °C (68°-77° F)

Inactive Ingredients

anhydrous citric acid, flavors, mannitol, neotame, sodium citrate monobasic, sucralose

Questions Or Comments?

1-800-331-4536 (Mon-Fri 9AM - 5PMEST)

Active Ingredient (in Each Tablet)

Aspirin 650 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug


Structured Label Content

Uses

temporarily relieves minor aches and pains due to: • headache • muscle pain • backache • menstrual cramps • minor pain of arthritis • temporarily reduces feve

Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

Purpose

Pain reliever/fever reducer

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 • facial swelling • asthma (wheezing) • shock 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

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 Ask a doctor before use if ● 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 ● gout ● diabetes ● arthritis 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 ● 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 ● ringing in the ears or a loss of hearing occurs 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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over: take contents of 1 powder pack every 6 hours. Dissolve powder on tongue, followed by a full glass of water. Do not exceed 4 powder packs in 24 hours. ● children under 12 years: consult a doctor

Other Information (Other information)

● phenylketonurics: contains phenylalanine 0.0017 mg per powder pack ● save carton for full directions and warnings ● Store between 20°- 25 °C (68°-77° F)

Inactive Ingredients

anhydrous citric acid, flavors, mannitol, neotame, sodium citrate monobasic, sucralose

Questions Or Comments? (Questions or comments?)

1-800-331-4536 (Mon-Fri 9AM - 5PMEST)

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin 650 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)