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NDC 63868-0122-96 Quality Choice Extra Strength Antacid Assorted Fruit 750 mg/1 Details

Quality Choice Extra Strength Antacid Assorted Fruit 750 mg/1

Quality Choice Extra Strength Antacid Assorted Fruit is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association 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: 63868-0122-96
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Calcium Carbonate

Product Information

NDC	63868-0122
Product ID	63868-122_923c8ec2-83a7-4978-b27c-3391dade6f09
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	Quality Choice Extra Strength Antacid Assorted Fruit
Proprietary Name Suffix	Extra Strength Antacid Assorted Fruit
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	Chain Drug Marketing Association 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	2024-12-31

Package

Package Images

NDC 63868-0122-96 (63868012296)

Pricing Information	N/A
NDC Package Code	63868-122-96
Billing NDC	63868012296
Package	96 TABLET, CHEWABLE in 1 BOTTLE (63868-122-96)
Marketing Start Date	2022-07-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 923c8ec2-83a7-4978-b27c-3391dade6f09 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:
wet in mouth before chewing
chew 2-4 tablets as symptoms occur, or as directed by a doctor.

OTHER INFORMATION

each tablet contains: elemental calcium 300 mg, magnesium 10 mg
do not use if printed seal under cap is torn or missing.
store below 30°C (86°F).

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

NDC 63868-122-96

QUALITY CHOICE

*Compare to the Active Ingredient in Extra Strength Tums®

Extra Strength

Antacid Tablets

Calcium Carbonate, 750 mg

Relieves :

Heartburn
Acid Indigestion

Assorted Fruit

96 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

QUALITY CHOICE EXTRA STRENGTH ANTACID ASSORTED FRUIT EXTRA STRENGTH ANTACID ASSORTED FRUIT

calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-122
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: 68401960MK)
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:63868-122-96	96 in 1 BOTTLE; Type 0: Not a Combination Product	07/19/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part331	07/19/2022

Labeler - Chain Drug Marketing Association Inc. (011920774)

Revised: 7/2022

Document Id: 923c8ec2-83a7-4978-b27c-3391dade6f09

Set id: 923c8ec2-83a7-4978-b27c-3391dade6f09

Version: 1

Effective Time: 20220726