Bayer Headache Ui 1600654

Bayer Headache Ui 1600654
SPL v4
SPL
SPL Set ID c0a92873-0914-6a86-e053-2995a90ac41c
Route
ORAL
Published
Effective Date 2021-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (500 mg) Caffeine (32.5 mg)
Inactive Ingredients
Carnauba Wax Hypromelloses Propylene Glycol D&c Yellow No. 10 Aluminum Lake Powdered Cellulose Titanium Dioxide Starch, Corn D&c Red No. 30 Triacetin Shellac

Identifiers & Packaging

Pill Appearance
Imprint: Bayer;Headache Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-28

Description

Drug Facts


Medication Information

Warnings and Precautions

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

Dosage and Administration

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: consult a doctor

Description

Drug Facts

Uses

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • toothache
    • colds
    • muscle pain
    • minor pain of arthritis
  • temporarily reduces fever
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50568-5

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

● gout

● diabetes

● arthritis

Section 50569-3

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

Section 50570-1

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

Section 51727-6

Inactive ingredients carnauba wax, corn starch, D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, hypromellose, powdered cellulose, propylene glycol, shellac, titanium dioxide, triacetin

Section 53413-1

Questions or comments? 1-800-331-4536 (Mon-Fri 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 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.

Section 55106-9

Active ingredients (in each caplet) Purpose

Aspirin 500 mg (NSAID)*………………………...................Pain reliever/fever reducer

Caffeine 32.5 mg……………………………….....................Pain reliever aid

*nonsteroidal anti-inflammatory drug

Section 60561-8

Other information

● save carton for full directions and warnings

● Store at room temperature. Avoid excessive heat above 40ºC (104ºF).

Package Display 50 Count Carton

Bayer®

ASPIRIN (NSAID)/PAIN RELIEVER/FEVER REDUCER CAFFEINE/PAIN RELIEVER AID

Headache

FAST RELIEF AT THE SITE OF PAIN

50 COATED CAPLETS

500 MG


Structured Label Content

Uses

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • toothache
    • colds
    • muscle pain
    • minor pain of arthritis
  • temporarily reduces fever
Dosage and Administration (34068-7)

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: consult a doctor

Warnings and Precautions (34071-1)

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients carnauba wax, corn starch, D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, hypromellose, powdered cellulose, propylene glycol, shellac, titanium dioxide, triacetin

Section 53413-1 (53413-1)

Questions or comments? 1-800-331-4536 (Mon-Fri 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 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.

Section 55106-9 (55106-9)

Active ingredients (in each caplet) Purpose

Aspirin 500 mg (NSAID)*………………………...................Pain reliever/fever reducer

Caffeine 32.5 mg……………………………….....................Pain reliever aid

*nonsteroidal anti-inflammatory drug

Section 60561-8 (60561-8)

Other information

● save carton for full directions and warnings

● Store at room temperature. Avoid excessive heat above 40ºC (104ºF).

Package Display 50 Count Carton

Bayer®

ASPIRIN (NSAID)/PAIN RELIEVER/FEVER REDUCER CAFFEINE/PAIN RELIEVER AID

Headache

FAST RELIEF AT THE SITE OF PAIN

50 COATED CAPLETS

500 MG


Advanced Ingredient Data


Raw Label Data

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