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

NDC 0536-3414-10

Rugby

Calcium Carbonate

Antacid

1000 Tablets

CALCIUM CARBONATE
calcium carbonate tablet

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-3414-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/12/1999	07/29/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	04/12/1999	07/29/2018

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

Rugby Laboratories Inc.