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Calcium carbonate by Rugby Laboratories Inc.

Medically reviewed on December 13, 2017

Dosage form: tablet
Ingredients: CALCIUM CARBONATE 648mg
Labeler: Rugby Laboratories Inc.
NDC Code: 0536-3414

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.

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

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (CALCIUM CATION and CARBONATE ION) CALCIUM CARBONATE648 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
Product Characteristics
ColorWHITE (off white) Scoreno score
ShapeROUNDSize11mm
FlavorImprint CodeAP;025
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-3414-101000 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33104/12/1999
Labeler - Rugby Laboratories Inc. (191427277)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical Inc.078301063MANUFACTURE(0536-3414)

 
Rugby Laboratories Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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