PLUS PHARMA CALCIUM ANTACID- calcium carbonate tablet, chewable

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

Buy It Now

Active ingredient:
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)
Available from:
A-S Medication Solutions
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antacid for the relief of - heartburn - sour stomach - acid indigestion - upset stomach associated with these symptoms
Product summary:
Product: 50090-4478 NDC: 50090-4478-0 150 TABLET, CHEWABLE in a BOTTLE, PLASTIC
Authorization status:
OTC monograph final
Authorization number:
50090-4478-0

PLUS PHARMA CALCIUM ANTACID- calcium carbonate tablet, chewable

A-S Medication Solutions

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.

----------

Drug Facts

Active ingredient (in each tablet)

Calcium Carbonate, USP 500 mg

Purpos e

Antacid

Us es

for the relief of

heartburn

sour stomach

acid indigestion

upset stomach associated with these symptoms

Warnings

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.

Ask a doctor or pharmacist before use if you are

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

If pregnant or breast-feeding,

ask a doctor before use.

Keep out of reach of children.

Directions

Adults and children 12 years and older

Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a doctor

Children under 12 years

Do not give to children under 12 years unless directed by a doctor

Other information

Each tablet contains: Elemental Calcium 195 mg

Each tablet contains: Sugar 1g

Do not exceed recommended dosage

Store at room temperature in a dry place

Do not use if clear neck seal is broken or missing

Inactive ingredients

Acacia, Artificial Cherry Flavor, Artificial Red Berry Flavor, Colloidal Silica, D and C Red #27 Lake,

FD and C Blue #1 Lake, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Natural and

Artificial Spearmint Flavor, Strach, Sucrose

Ques tions ?

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

HOW SUPPLIED

Product: 50090-4478

NDC: 50090-4478-0 150 TABLET, CHEWABLE in a BOTTLE, PLASTIC

CALCIUM CARBONATE

PLUS PHARMA CALCIUM ANTACID

calcium carbonate tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 0 9 0 -4478 (NDC:516 45-735)

Route of Administration

ORAL

A-S Medication Solutions

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

ACACIA (UNII: 5C540 3N26 O)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

D&C RED NO . 2 7 (UNII: 2LRS18 5U6 K)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

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

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

STARCH, CO RN (UNII: O8 232NY3SJ)

SUCRO SE (UNII: C151H8 M554)

Product Characteristics

Color

pink (cherry flavo r) , white (spearmint flavo r) , blue (grape flavo r)

S core

no sco re

S hap e

ROUND (flat faced beveled edge unco ated)

S iz e

16 mm

Flavor

CHERRY (pink tablet) , SPEARMINT (white tablet) , GRAPE (blue tablet)

Imprint Code

GPI;1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:50 0 9 0 -4478 -

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

Pro duc t

0 8 /27/20 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 3/27/20 0 6

Labeler -

A-S Medication Solutions (830016429)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

A-S Medicatio n So lutio ns

8 30 0 16 429

RELABEL(50 0 9 0 -4478 )

Revised: 8/2019

Similar products

Search alerts related to this product

View documents history

Share this information