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NDC 69842-0173-92 Extra Strength Smooth Antacid Assorted Fruit 750 mg/1 Details

Extra Strength Smooth Antacid Assorted Fruit 750 mg/1

Extra Strength Smooth Antacid Assorted Fruit is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by CVS. 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: 69842-0173-92
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Calcium Carbonate

Product Information

NDC	69842-0173
Product ID	69842-173_e974ee4d-e008-4907-b46a-b088fa6f153a
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 Assorted Fruit
Proprietary Name Suffix	n/a
Non-Proprietary Name	Calcium antacid
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	CVS
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 69842-0173-92 (69842017392)

Pricing Information	N/A
NDC Package Code	69842-173-92
Billing NDC	69842017392
Package	60 TABLET, CHEWABLE in 1 BOTTLE (69842-173-92)
Marketing Start Date	2014-11-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ed808369-ef51-4977-9497-c0cb7e79ac6e Details

Active ingredient (in each tablet)

Calcium carbonate 750 mg

Purpose

Antacid

SPL UNCLASSIFIED SECTION

Uses

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 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.

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, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C yellow 6 lake, FD&C red 40 lake, flavors, microcrystalline cellulose, magnesium stearate, maltodextrin, sorbitol, sucrose, talc

PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient inTUMS® Smooth Extra Strength

Extra Strength Smooth Antacid Tablets

Calcium Carbonate 750 mg

Assorted Fruit Flavor

140 chewable Tablets

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH SMOOTH ANTACID ASSORTED FRUIT

calcium antacid tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-173
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	750 mg

Ingredient Name	Strength
Inactive Ingredients
ADIPIC ACID (UNII: 76A0JE0FKJ)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	pink, orange, yellow, red	Score	no score
Shape	ROUND	Size	16mm
Flavor	FRUIT (lemon, strawberry, cherry, orange)	Imprint Code	G173
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-173-94	140 in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2016
2	NDC:69842-173-92	60 in 1 BOTTLE; Type 0: Not a Combination Product	11/03/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	11/03/2014

Labeler - CVS (062312574)

Revised: 5/2017

Document Id: e974ee4d-e008-4907-b46a-b088fa6f153a

Set id: ed808369-ef51-4977-9497-c0cb7e79ac6e

Version: 2

Effective Time: 20170508