EXTRA STRENGTH ANTACID ORIGINAL FLAVOR- aluminum hydroxide and magnesium carbonate tablet, chewable

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

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Active ingredient:
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0), MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)
Available from:
CHAIN DRUG MARKETING ASSOCIATION INC.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antacid Antacid relieves
Authorization status:
OTC monograph final
Authorization number:
63868-996-01

EXTRA STRENGTH ANTACID ORIGINAL FLAVOR- aluminum hydroxide and magnesium

carbonate tablet, chewable

CHAIN DRUG MARKETING ASSOCIATION INC.

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.

----------

Quality Choice Antacid Tablets Extra Strength Original Flavor

Active ingredients (in each tablet)

Aluminum hydroxide 160 mg

Magnesium carbonate 105 mg

Purpose

Antacid

Antacid

Uses

relieves

Warnings

Ask a doctor or pharmacist before use if you are

When using this product

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

1-800-222-1222

Directions

acid indigestion

heartburn

sour stomach

upset stomach associated with these symptoms

taking a prescription drug. Antacids may interact with certain prescription drugs

on a sodium-restricted diet

do not take more than 16 tablets in 24 hours

do not use the maximum dosage for more than 2 weeks

chew 2 to 4 tablets four times a day or as directed by a doctor

take after meals and at bedtime or as needed

Other information

Inactive ingredients

alginic acid, calcium stearate, compressible sugar, flavor, sodium bicarbonate, starch (corn), sucrose.

Questions or comments

1-866-467-2748

Principal Display Panel

QUALITY CHOICE®

NDC 63868-996-01

Compare To Gaviscon® active ingredients*

Extra Strength

Antacid Tablets

Foaming

Long Lasting Antacid Barrier

Fast Acting Heartburn Relief

Original Flavor

100% QC SATISFACTION GUARANTEED

*This product is not manufactured or distributed by GlaxoSmithKline, the distributor of Gaviscon

Extra Strength.

for best results follow by a half glass of water or other liquid

DO NOT SWALLOW WHOLE

each tablet contains: sodium 19 mg, magnesium 31 mg.

Store at up to 25°C (77°F) in a dry place.

DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

EXTRA STRENGTH ANTACID ORIGINAL FLAVOR

aluminum hydroxide and magnesium carbonate tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 38 6 8 -9 9 6

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 ) (ALUMINUM HYDROXIDE -

UNII:5QB0 T2IUN0 )

ALUMINUM HYDROXIDE

16 0 mg

MAGNESIUM CARBO NATE (UNII: 0 E53J9 27NA) (CARBONATE ION - UNII:7UJQ5OPE7D)

MAGNESIUM

CARBONATE

10 5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ALGINIC ACID (UNII: 8 C3Z4148 WZ)

CALCIUM STEARATE (UNII: 776 XM70 47L)

CO RN SYRUP (UNII: 9 G5L16 BK6 N)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

STARCH, CO RN (UNII: O8 232NY3SJ)

SUCRO SE (UNII: C151H8 M554)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

17mm

Flavor

BUTTERSCOTCH (ORIGINAL)

Imprint Code

RP10 5

Contains

CHAIN DRUG MARKETING ASSOCIATION INC.

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 38 6 8 -9 9 6 -

10 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/19 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt331

0 4/19 /20 19

Labeler -

CHAIN DRUG MARKET ING ASSOCIAT ION INC. (011920774)

Revised: 4/2019

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