GOODSENSE REGULAR STRENGTH ANTACID PEPPERMINT - calcium carbonate tablet, chewable

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)
Available from:
GoodSense
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antacid relieves: - acid indigestion - heartburn - presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Authorization status:
OTC monograph final
Authorization number:
50804-113-17

GOODSENSE REGULAR STRENGTH ANTACID PEPPERMINT - calcium carbonate tablet,

chewable

GoodSens e

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Goodsense Regular Strength Antacid Peppermint Chewable Tablets

ACTIVE INGREDIENT (in each tablet)

Calcium carbonate 500 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 15 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 200 mg

do not use if seal under the cap is torn or missing.

store at room temperature. keep the container tightly closed.

INACTIVE INGREDIENTS

corn starch, crospovidone, dextrose, flavor, magnesium stearate, maltodextrin, sucrose, talc.

PRINCIPAL DISPLAY PANEL

GOODSENSE

Regular Strength

NDC 50804-113-17

Antacid Tablets

Calcium Carbonate 500 mg

Fast Relief of

Acid indigestion

Heartburn

Upset Stomach

Peppermint Flavor

*Compare to the active ingredient of Regular Strength Tums®

150 Chewable Tablets

GOODSENSE REGULAR STRENGTH ANTACID PEPPERMINT

calcium carbonate tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 8 0 4-113

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CALCIUM CARBO NATE (UNII: H0 G9 379 FGK) (CALCIUM CATION - UNII:2M8 3C4R6 ZB)

CALCIUM CARBONATE

50 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

GoodSense

STARCH, CO RN (UNII: O8 232NY3SJ)

DEXTRO SE, UNSPECIFIED FO RM (UNII: IY9 XDZ35W2)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

SUCRO SE (UNII: C151H8 M554)

TALC (UNII: 7SEV7J4R1U)

CRO SPO VIDO NE, UNSPECIFIED (UNII: 2S78 30 E56 1)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

16 mm

Flavor

PEPPERMINT

Imprint Code

G113

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 8 0 4-113-17

150 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/20 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt331

0 8 /0 8 /20 18

Labeler -

GoodSense (076059836)

Revised: 8/2018

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