Calgest by Rugby Laboratories Inc. / Advance Pharmaceutical Inc. CalGest Antacid Tablets

Calgest by

Drug Labeling and Warnings

Calgest 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]

CALGEST- calgest 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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CalGest Antacid Tablets

Active Ingredient

(in each chewable tablet)

Calcium carbonate 500 mg

Purpose

Antacid

Use

relieves

• acid indigestion
• heartburn
• sour stomach

Warnings

Ask a doctor before use if you have

• Kidney stones
• a calcium-restricted diet
•   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.
•   Keep out of reach of children.

Directions

• chew 1-2 tablets as symptoms occur
• do not take more than 8 tablets in 24 hours
• do not use the maximum dosage for more than 2 weeks

Other Information

• Each tablet contains: calcium 200 mg
• store at room temperature

Inactive Ingredients

Al-lakes (D&C red #27, D&C yellow #10, FD&C blue #1, FD&C yellow #6), dextrose, flavors, magnesium stearate, maltodextrin

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 0536-3742-97

Rugby

Cal.Gest Antacid

150 Chewable Tablets

CALGEST 
calgest tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-4742
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	500 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	YELLOW (light) , PINK (light) , GREEN (light)	Score	no score
Shape	ROUND	Size	16mm
Flavor	LEMON (LIME,ORANGE,CHERRY)	Imprint Code	AP;043
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-4742-97	150 in 1 BOTTLE; Type 0: Not a Combination Product	01/23/1996	07/29/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	01/23/1996	07/29/2018

Labeler - Rugby Laboratories Inc. (079246066)

Revised: 12/2019

Document Id: ee583c97-059c-476f-9735-702578c4006e

34390-5

Set id: 6e86dda6-b4e0-4653-aaae-c2d502e0bf78

Version: 6

Effective Time: 20191220

 

Rugby Laboratories Inc.