Acid Reducer Plus Antacid Tablet, Chewable
FDA Label NDC 11822-0223

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Acid Reducer Plus Antacid (NDC 11822-0223). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each chewable tablet), purposes, use, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients (in Each Chewable Tablet)

→ Purposes

→ Use

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredients (In Each Chewable Tablet)

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Purposes

Acid reducer

Antacid

Use

relieves heartburn associated with acid indigestion and sour stomach

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do Not Use

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
with other acid reducers

Ask A Doctor Before Use If You Have

had heartburn over 3 months. This may be a sign of a more serious condition.
heartburn with lightheadedness, sweating, or dizziness
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
kidney disease

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs.

Stop Use And Ask A Doctor If

your heartburn continues or worsens
you need to take this product for more than 14 days

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

adults and children 12 years and over:
do not swallow tablet whole: chew completely
to relieve symptoms, chew 1 tablet before swallowing
do not use more than 2 chewable tablets in 24 hours
children under 12 years: ask a doctor

Other Information

each tablet contains: calcium 330 mg; magnesium 80 mg
Phenylketonurics: Contains phenylalanine 2 mg per tablet
read the directions and warnings before use
read the bottle. It contains important information.
store at 20-25˚C (68-77˚F)
protect from moisture

Inactive Ingredients

anhydrous lactose, aspartame, dextrates, ferric oxide, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, natural peppermint flavor, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc