Active Ingredient (Per Tablet)
Calcium Carbonate USP 750 mg
Antacid
FDA Label NDC 61010-4408
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safetec Of America, Inc. for the product Antacid (NDC 61010-4408). 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 ingredient (per tablet), purpose, indications & usage, otc - ask doctor/pharmacist, when using this product, keep out of reach of children., other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid
Indications & Usage
Uses relieves
- heartburn
- acid indigestion
- sour stomach
- upset stomach associated with these symptoms
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
When Using This Product
- do not take more than 10 tablets in 24 hours
- if pregnant do not take more than 6 tablets in 24 hours
- do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
Keep Out Of Reach Of Children.
- adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor
- do not take for symptoms that persist for more than 2 weeks unless advised by a doctor
Other Information
- each tablet contains: calcium 300 mg
- store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients
dextrose, flavor (peppermint), magnesium stearate, maltodextrin
Questions Or Comments?
Call toll free: 1-800-456-7077
Principal Display Panel - 750 Mg Pouch Label
Safetec
of America, Inc.
DO NOT USE IF POUCH IS TORN OR DAMAGED
Manufactured for Safetec of America, Inc.
Buffalo NY 14215
EXTRA STRENGTH
Antacid
Calcium Carbonate 750 mg
2 Chewable Tablets
Principal Display Panel (750 mg Pouch Label)
Principal Display Panel – 50 Count Carton
Safetec®
of America, Inc.
*Compare to the active
ingredient in TUMS® EX
NDC 61010-4408-1
Antacid
Calcium Carbonate 750 mg – Extra Strength
- Fast heartburn relief
- Relieves acid indigestion
TAMPER EVIDENT UNIT DOSE POUCHES
DO NOT USE IF POUCH IS TORN OR DAMAGED
50 Pouches 2 Tablets per pouch
Principal Display Panel – 50 Count Carton (Ant0i 0001 02)
Principal Display Panel – 100 Count Carton
Safetec®
of America, Inc.
*Compare to the active
ingredient in TUMS® EX
NDC 61010-4408-2
Antacid
Calcium Carbonate 750 mg – Extra Strength
- Fast heartburn relief
- Relieves acid indigestion
PUSH TO OPEN
Dispense
through opening
TAMPER EVIDENT UNIT DOSE POUCHES
DO NOT USE IF POUCH IS TORN OR DAMAGED
100 Pouches 2 Tablets per pouch
Principal Display Panel – 100 Count Carton (Ant0i 0001 03)
* Please review the disclaimer below.
