Rugby Cal-gest Antacid Tablet, Chewable
FDA Label NDC 0536-1007

9 label sections · Submitted to the FDA by Rugby Laboratories, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories, Inc. for the product Rugby Cal-gest Antacid (NDC 0536-1007). 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, uses, warnings, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (Per Tablet)

Calcium Carbonate USP 500mg

Purpose

Antacid

Uses

relieves:

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms

Warnings

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

  • do not take more than 15 tablets in 24 hours
  • if pregnant do not take more than 10 tablets in 24 hours.
  • do not use the maximum dosage for more than 2 weeks except under advice and supervision of a doctor

Directions

  • 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: elemental calcium 200 mg
  • Store at room temperature. Keep the container tightly closed

Inactive Ingredients

adipic acid, D&C red#27 lake, D&C yellow# 10 lake, dextrose, FD&C blue #1 lake, FD&C yellow #6 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

Questions Or Comments?

1-800-645-2158

Package/Label Principal Display Panel

COMPARE TO active ingredient in TUMS®*

NDC# 0536-1007-15

Rugby®

CALCIUM

Cal-Gest®

Antacid Tablets

Regular Strength

Calcium Carbonate 500 mg

Assorted Fruit

Naturally & Artificially Flavored

150 CHEWABLE TABLETS

Safety sealed: Do not use if printed seal under cap is torn or missing

GLUTEN-FREE

*This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Regular Strength Tums®

Distributed by Rugby Laboratories

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152, USA

www.rugbylaboratories.com

Rugby Cal-gest Antacid Tablets 150 Chewable Tablets (A43184c4 D225 4539 B651 4d96535f208f 01)

Rugby Cal-gest Antacid Tablets 150 Chewable Tablets (A43184c4 D225 4539 B651 4d96535f208f 01)

* Please review the disclaimer below.