Calcium Carbonate Tablets

Drug Labeling and Warnings

Drug Details [pdf]

CALCIUM CARBONATE - calcium carbonate tablet 
Bryant Ranch Prepack

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

HOW SUPPLIED

Product: 63629-3757

Calcium Carbonate 10gr.(648mg) Tablet

CALCIUM CARBONATE 
calcium carbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63629-3757(NDC: 0536-3414)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	648 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE (off white)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	AP;025
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63629-3757-1	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2008	03/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	04/12/1999	03/01/2010

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(63629-3757) , RELABEL(63629-3757)

Revised: 10/2019

Document Id: b05cef98-ad1c-4b30-9b12-ff3481354767

34390-5

Set id: 8a309142-59ec-4297-bed1-14f7612ff6c2

Version: 1002

Effective Time: 20191001