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NDC 71713-0204-03 Extra Strength Smooth Antacid 750 mg/1 Details

Extra Strength Smooth Antacid 750 mg/1

Extra Strength Smooth Antacid is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Thirty Madison Inc. 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: 71713-0204-03
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Calcium Carbonate

Product Information

NDC	71713-0204
Product ID	71713-204_966f739d-4d4c-40aa-add8-430fa7f3654f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Extra Strength Smooth 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	Thirty Madison Inc
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	2023-12-31

Package

Package Images

NDC 71713-0204-03 (71713020403)

Pricing Information	N/A
NDC Package Code	71713-204-03
Billing NDC	71713020403
Package	60 TABLET, CHEWABLE in 1 BOTTLE (71713-204-03)
Marketing Start Date	2019-05-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 95fcaed0-b761-4e6e-a1a6-184dc3ba0548 Details

ACTIVE INGREDIENT (in each tablet)

Calcium carbonate 750 mg

PURPOSE

Antacid

USE(S)

relieves:

acid indigestion
heartburn
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 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 BREAST FEEDING,

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.
do not take for symptoms that persists for more than 2 weeks unless advised by a doctor.

OTHER INFORMATION

each tablet contains: elemental calcium 300 mg
store at room temperature. keep the container tightly closed.

INACTIVE INGREDIENTS

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

PRINCIPAL DISPLAY PANEL

Extra Strength

Smooth

Antacid Tablets

evens

Chill Berries

Calcium Carbonate 750 mg

60 Chewable Tablets

Compare to the active ingredient in TUMS®SmoothiesTM EX

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH SMOOTH ANTACID

calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71713-204
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)
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)
SORBITOL (UNII: 506T60A25R)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	RED (light red) , BLUE (light blue) , PINK (light pink)	Score	no score
Shape	ROUND	Size	16mm
Flavor	BERRY (STRAWBERRY, RASPBERRY, WIDBERRY) , CHERRY	Imprint Code	G173
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71713-204-03	60 in 1 BOTTLE; Type 0: Not a Combination Product	05/17/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part331	05/17/2019

Labeler - Thirty Madison Inc (080774087)

Revised: 1/2022

Document Id: 966f739d-4d4c-40aa-add8-430fa7f3654f

Set id: 95fcaed0-b761-4e6e-a1a6-184dc3ba0548

Version: 3

Effective Time: 20220106