Rolaids Acid Defense
Drug Facts
Rolaids Tablet
FDA Label NDC 84126-367
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Rolaids (NDC 84126-367). 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 rolaids acid defense, active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharnacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Famotidine 20 mg
Purpose
Acid reducer
Uses
- relieves heartburn associated with acid indigestion and sour stomach
- prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
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.
- with other acid reducers
These may be signs of a serious condition.
See your doctor.
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 Pharnacist Before Use If You Are
taking a prescription drug. 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 mor than 14 days
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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:
- to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
- to prevent symptoms, swallow 1 tabelt with a glass of water any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
- do not use more than 2 tablets in 24 hours
children under 12 years; ask a doctor
Other Information
- read the directions and warnings before use
- keep the carton. It contains important information.
- store at 20° - 25°C (68° - 77°F)
- protect from moisture
Inactive Ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide
Questions Or Comments?
1-833-372-2729
Other
TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS MISSING OR DAMAGED
DIST. BY:
PROCTER & GAMBLE,
CINCINNATI, OH 45202
Principal Display Panel
MAXIMUM STRENGTH
Rolaids
ACID DEFENSE
FAMOTIDINE TABLETS, 20MG
ACID REDUCER
JUST 1 TABLET!
PREVENTS &
RELIEVES
HEARTBURN
DUE TO ACID INDIGESTION
25 TABLETS
367 (367)
* Please review the disclaimer below.
