Drugplain

Bayer Headache 500 mg/1

Aspirin and caffeine · TABLET · Bayer HealthCare LLC.

No Recall History
Plain English

Bayer Headache is a tablet containing aspirin and caffeine at 500 mg/1, taken oral. Manufactured by Bayer HealthCare LLC..

Key Facts

Brand Name
Bayer Headache
Generic Name
Aspirin and caffeine
NDC Code (Product)
0280-0064
Manufacturer
Bayer HealthCare LLC.
Strength
500 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M013
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
Marketing Start
04/28/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

headache3 reports
nausea2 reports
urinary tract infection2 reports
abdominal discomfort1 reports
abdominal pain1 reports
anaemia1 reports
back pain1 reports
cardiac arrest1 reports
cardiovascular disorder1 reports
cough1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Uses temporarily relieves minor aches and pains due to: headache toothache colds muscle pain minor pain of arthritis temporarily reduces fever

Dosage & 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

Warnings

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

Frequently Asked Questions

What is Bayer Headache used for?

Bayer Headache contains Aspirin and caffeine. It is a tablet taken oral. Consult your doctor for specific uses.

Is Bayer Headache a controlled substance?

Bayer Headache is not classified as a controlled substance by the DEA.

What is the generic name for Bayer Headache?

The generic name for Bayer Headache is Aspirin and caffeine. There are 11 other brand versions of Aspirin and caffeine.

What is the NDC code for Bayer Headache 500 mg/1?

The NDC (National Drug Code) for Bayer Headache 500 mg/1 is 0280-0064, listed by Bayer HealthCare LLC..