Alka-Seltzer Pain Relief

FDA Drug Profile — Alka-Seltzer Pain Relief

Drug Details

Generic Name
Alka-Seltzer Pain Relief
Brand Names
Alka-Seltzer Pain Relief
Application Number
M013
Sponsor
Bayer HealthCare LLC.
NDC Codes
1
Dosage Forms
TABLET, EFFERVESCENT
Routes
ORAL
Active Ingredients
ASPIRIN

Indications and Usage

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

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 STOMACH WARNING: TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK. Consult a doctor if severe stomach pain occurs after taking this product.