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NDC 50804-0171-68 GOODSENSE Ultra Strength Antacid Assorted Fruit 1000 mg/1 Details

GOODSENSE Ultra Strength Antacid Assorted Fruit 1000 mg/1

GOODSENSE Ultra Strength Antacid Assorted Fruit is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by GoodSense. 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: 50804-0171-68
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Calcium Carbonate

Product Information

NDC	50804-0171
Product ID	50804-171_cbcc2e13-b925-4555-88ab-eec9d5b05d5e
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	GOODSENSE Ultra Strength Antacid Assorted Fruit
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	GoodSense
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 50804-0171-68 (50804017168)

Pricing Information	N/A
NDC Package Code	50804-171-68
Billing NDC	50804017168
Package	72 TABLET, CHEWABLE in 1 BOTTLE (50804-171-68)
Marketing Start Date	2018-08-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ad4d51f6-b55b-45db-b034-fb3da54fbe99 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 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

GOODSENSE

NDC 50804-171-68

Ultra Strength

Antacid

TABLETS

Calcium Carbonate 1000 mg

Fast Relief of

Acid indigestion
Heartburn
Upset stomach

Assorted Fruit Flavors

*Compare to active ingredient of Ultra Strength Tums®

72 Chewable Tablets

INGREDIENTS AND APPEARANCE

GOODSENSE ULTRA STRENGTH ANTACID ASSORTED FRUIT

calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-171
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--ALUMINUM LAKE (UNII: J9EQA3S2JM)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
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	17mm
Flavor	CHERRY, LEMON, LIME, ORANGE	Imprint Code	G171
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50804-171-68	72 in 1 BOTTLE; Type 0: Not a Combination Product	08/08/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part331	08/08/2018

Labeler - GoodSense (076059836)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	MANUFACTURE(50804-171)

Revised: 1/2022

Document Id: cbcc2e13-b925-4555-88ab-eec9d5b05d5e

Set id: ad4d51f6-b55b-45db-b034-fb3da54fbe99

Version: 2

Effective Time: 20220111