LEADER EXTRA STRENGTH ANTACID- calcium carbonate tablet, chewable

Leader Extra Strength Antacid by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT (in each tablet)

Calcium carbonate 750 mg

PURPOSE

Antacid

USE(S)

relieves:

• acid indigestion
• heartburn

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 10 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

IF PREGNANT OR/BREASTFEEDING,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

.

DIRECTIONS

• adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor.

OTHER INFORMATION

• each tablet contains: elemental calcium 300 mg
• do not use if printed seal under cap is torn or missing. 
• store at room temperature.Keep the container tightly closed.

INACTIVE INGREDIENTS

adipic acid, corn starch, crospovidone, D&C red 27 lake, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

PRINCIPAL DISPLAY PANEL

Leader™
NDC: 70000-0430-2
Extra Strength Antacid Tablets
Calcium Carbonate, 750 mg
Assorted Fruit Flavor

Relief of :
Heartburn and
Acid Indigestion

COMPARE TO TUMS® EXTRA STRENGTH active ingredient*

96 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

LEADER EXTRA STRENGTH ANTACID 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0430
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	750 mg

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID (UNII: 76A0JE0FKJ)
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	ORANGE, YELLOW, GREEN, PINK (reddish pink)	Score	no score
Shape	ROUND	Size	16mm
Flavor	CHERRY, LEMON, LIME, ORANGE	Imprint Code	G127
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0430-2	96 in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part331	07/10/2019

Labeler - Cardinal Health (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(70000-0430)