ANTACID ULTRA STRENGTH- calcium carbonate tablet, chewable
Western Family Foods 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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Western Family Antacid Drug Facts

Active ingredient (in each tablet)

Calcium carbonate USP 1,000mg

Purpose

Antacid

Uses

relieves

•: heartburn
•: sour stomach
•: acid indigestion
•: upset stomach associated with these symptoms

Warnings

Ask a doctor or pharmacist before use if you are

•: now taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

•: do not take more than 7 tablets in 24 hours
•: do not use the maximum dosage for more than 2 weeks

Keep out of reach of children.

Directions

•: chew 2-3 tablets as symptoms occur, or as directed by a doctor

Other information

•: each tablet contains: calcium 430 mg and magnesium 10 mg
•: store at 20-25°C (68-77°F)

Inactive ingredients

adipic acid, blue #1 aluminum lake, dextrose, flavors, maltodextrin, mineral oil, polyethylene glycol, powdered cellulose, red #40 aluminum lake, talc, yellow #5 aluminum lake (tartrazine), yellow #6 aluminum lake

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Antacid

Antacid/Calcium Supplement

Ultra Strength 1000

Calcium Carbonate

1,000 mg

Assorted Fruit

NATURALLY AND ARTIFICIALLY FLAVORED

COMPARE TO TUMS® ULTRA STRENGTH 1000 Active Ingredient

72 Chewable Tablets

ANTACID ULTRA STRENGTH
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55312-444
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	1000 mg

Ingredient Name	Strength
Inactive Ingredients
ADIPIC ACID (UNII: 76A0JE0FKJ)
DEXTROSE (UNII: IY9XDZ35W2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	YELLOW, GREEN, RED, ORANGE	Score	no score
Shape	ROUND	Size	20mm
Flavor	FRUIT (lime, orange, cherry, lemon)	Imprint Code	L595
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55312-444-23	72 in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2014	11/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	04/21/2014	11/01/2018

Labeler - Western Family Foods Inc (192166072)

Revised: 10/2018

Document Id: 4be83175-ac7a-44a7-bf4d-31fa23a2cc63

Set id: 62716807-7255-424f-b2bb-5f271d3c18c8

Version: 2

Effective Time: 20181019

Western Family Foods Inc