Calcium Carbonate Tablets

Calcium carbonate by

Drug Labeling and Warnings

Calcium carbonate by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories Inc., Advance Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CALCIUM CARBONATE- calcium carbonate tablet 
Rugby Laboratories Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Calcium Carbonate Tablets

Active Ingredient

(in each tablet)

Calcium carbonate 10 gr (648 mg)

Purpose

Antacid

Use

relieves

  • acid indigestion
  • heartburn
  • sour stomach
  • 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.

Stop use and ask a doctor if symptoms last more than 2 weeks.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Directions

  • take one to four tablets daily
  • do not take more than 4 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks

Other Information

  • Each tablet contains: calcium 260 mg
  • store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

croscarmellose sodium, magnesium sterate, maltodextrin, microcrystalline cellulose, stearic acid

Questions or Comments

Call 1-800-645-2158, Monday – Friday, 9 am – 5 pm ET

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

This is a bulk pakage, dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Mfd for: Rugby Laboratories,Inc

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

072d6298-figure-01

NDC: 0536-3414-10

Rugby

Calcium Carbonate

Antacid

1000  Tablets

CALCIUM CARBONATE 
calcium carbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-3414
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE648 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITE (off white) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code AP;025
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0536-3414-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/12/199907/29/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33104/12/199907/29/2018
Labeler - Rugby Laboratories Inc. (079246066)

Revised: 12/2019
Document Id: b130f680-853a-4301-8a1c-38e951cb1960
Set id: 3c2cb040-c9f8-4e4f-9ebc-da00f9d06806
Version: 3
Effective Time: 20191220