Leader Extra Strength Effervescent Antacid and Pain Reliever
Generic: ASPIRIN, CITRIC ACID, SODIUM BICARBONATE
Basic Information
Manufacturer
Cardinal Health
Product Type
HUMAN OTC DRUG
Route of Administration
ORAL
FDA Set ID
c5d7bf5f-3e59-52f2-e053-2a95a90a4a00
Purpose
Purpose (in each effervescent tablet) Anhydrous citric acid 1000 mg..............................................................Antacid Aspirin 500 mg (NSAID) *......................................................................Pain Reliever Sodium bicarbonate (heat-treated) 1985 mg........................................Antacid *Nonsteroidal anti-inflammatory drug
Indications & Usage
Uses Uses for the temporary relief of ■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains ■ upset stomach with headache from overindulgence in food or drink ■ headache, body aches and pain alone
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
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