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NDC 70000-0430-02 Leader Extra Strength Antacid 750 mg/1 Details

Leader Extra Strength Antacid 750 mg/1

Leader Extra Strength Antacid is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by CARDINAL HEALTH 110, LLC. DBA LEADER. The primary component is CALCIUM CARBONATE.

MedlinePlus Drug Summary

Calcium carbonate is a dietary supplement used when the amount of calcium taken in the diet is not enough. Calcium is needed by the body for healthy bones, muscles, nervous system, and heart. Calcium carbonate also is used as an antacid to relieve heartburn, acid indigestion, and upset stomach. It is available with or without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 70000-0430-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Calcium Carbonate

Product Information

NDC	70000-0430
Product ID	70000-0430_330f85cb-99db-4b19-acd1-cf5d77c41b8d
Associated GPIs	48300010000520
GCN Sequence Number	002690
GCN Sequence Number Description	calcium carbonate TAB CHEW 300MG(750) ORAL
HIC3	D4B
HIC3 Description	ANTACIDS
GCN	07894
HICL Sequence Number	001163
HICL Sequence Number Description	CALCIUM CARBONATE
Brand/Generic	Generic
Proprietary Name	Leader Extra Strength Antacid
Proprietary Name Suffix	n/a
Non-Proprietary Name	Calcium carbonate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	750
Active Ingredient Units	mg/1
Substance Name	CALCIUM CARBONATE
Labeler Name	CARDINAL HEALTH 110, LLC. DBA LEADER
Pharmaceutical Class	Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part331
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0430-02 (70000043002)

Pricing Information
NDC Package Code	70000-0430-2
Billing NDC	70000043002
Package	96 TABLET, CHEWABLE in 1 BOTTLE (70000-0430-2)
Marketing Start Date	2019-07-10
NDC Exclude Flag	N
Price Per Unit	0.02774
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	ANTACID EX-STR 750 MG TAB CHEW
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL c7a8c877-3e20-4910-8ea4-1714fac3ff2f Details

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

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

Ingredient Name	Strength
Inactive Ingredients
ADIPIC ACID (UNII: 76A0JE0FKJ)
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (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

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

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

Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)

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

Revised: 1/2022

Document Id: 330f85cb-99db-4b19-acd1-cf5d77c41b8d

Set id: c7a8c877-3e20-4910-8ea4-1714fac3ff2f

Version: 2

Effective Time: 20220110