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NDC 70000-0436-01 Leader Ultra Strength Antacid 1000 mg/1 Details

Leader Ultra Strength Antacid 1000 mg/1

Leader Ultra 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: 70000-0436-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Calcium Carbonate

Product Information

NDC	70000-0436
Product ID	70000-0436_89423db3-9c88-42f2-9bcf-0968d0d0085d
Associated GPIs	48300010000545
GCN Sequence Number	021697
GCN Sequence Number Description	calcium carbonate TAB CHEW 400(1000) ORAL
HIC3	D4B
HIC3 Description	ANTACIDS
GCN	07896
HICL Sequence Number	001163
HICL Sequence Number Description	CALCIUM CARBONATE
Brand/Generic	Generic
Proprietary Name	Leader Ultra 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	1000
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 70000-0436-01 (70000043601)

Pricing Information
NDC Package Code	70000-0436-1
Billing NDC	70000043601
Package	72 TABLET, CHEWABLE in 1 BOTTLE (70000-0436-1)
Marketing Start Date	2019-07-10
NDC Exclude Flag	N
Price Per Unit	0.03598
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	ANTACID ULTRA STR 1,000 MG CHW
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 eab5a905-67fb-494e-8f55-aeeab4c2dce2 Details

ACTIVE INGREDIENT (in each tablet)

Calcium carbonate 1000 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 7 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 2-3 tablets as symptoms occur, or as directed by a doctor.

OTHER INFORMATION

each tablet contains: elemental calcium 400 mg
do not use if printed seal under the cap is torn or missing
store at room temperature. keep the container tightly closed.

INACTIVE INGREDIENTS

adipic acid, corn starch, crospovidone, dextrose, FD&C blue 1 lake, FD&C red 40 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0436-1

Ultra Strength

Antacid

Tablets

Calcium Carbonate 1000 mg

Assorted Berry Flavor

Relief of:

Heartburn and

Acid Indigestion

COMPARE TO TUMS® ULTRA STRENGTH active ingredient*

72 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

LEADER ULTRA STRENGTH ANTACID

calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0436
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	1000 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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	BLUE, PINK, PINK (PINKISH BLUE)	Score	no score
Shape	ROUND	Size	17mm
Flavor	BERRY (STRAWBERRY, RASPBERRY, WIDBERRY)	Imprint Code	G171
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0436-1	72 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(70000-0436)

Revised: 1/2022

Document Id: 89423db3-9c88-42f2-9bcf-0968d0d0085d

Set id: eab5a905-67fb-494e-8f55-aeeab4c2dce2

Version: 2

Effective Time: 20220110