Cardinal Health Antacid Tablets Drug Facts

Leader Antacid by

Drug Labeling and Warnings

Leader Antacid by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LEADER ANTACID- calcium carbonate tablet, chewable 
Cardinal Health

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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Cardinal Health Antacid Tablets Drug Facts

Active ingredient (in each tablet)

Calcium carbonate USP 1000mg

Purpose

Antacid

Uses

relieves

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

Warnings

Ask a doctor or pharmacist before use if you are

presently 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
• if pregnant do not take more than 5 tablets in 24 hours
• do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Keep out of reach of children.

Directions

• adults and children 12 years of age and over: chew 2-3 tablets as symptoms occur, or as directed by a doctor
• do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other information

• each tablet contains:calcium 430mg
• store at 20-25°C (68-77°F)
• does not meet USP for assay

Inactive ingredients

citric acid, dextrose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #5 aluminum lake (tartrazine), FD&C yellow #6 aluminum lake, flavors, glycerin, magnesium stearate, maltodextrin, mineral oil

Questions?

1-800-719-9260

Principal Display Panel

Compare to Tums® Ultra Strength 1000 active ingredient

ULTRA STRENGTH

Antacid Tablets

Calcium Carbonate 1000 mg

Starts working in seconds!

Assorted Fruit Flavors

K PAREVE

72 CHEWABLE TABLETS

LEADER ANTACID 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49781-119
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	1000 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DEXTROSE (UNII: IY9XDZ35W2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MINERAL OIL (UNII: T5L8T28FGP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49781-119-72	72 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2014	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	09/30/2014	03/01/2020

Labeler - Cardinal Health (097537435)

Revised: 1/2019

Document Id: 427cb01b-a385-4ac4-84af-b952fc543b4e

34390-5

Set id: c3c3828a-4b00-4fcc-972b-b6372510f5a0

Version: 3

Effective Time: 20190103