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NDC 54738-0030-15 ANTACID 500 mg/1 Details

ANTACID 500 mg/1

ANTACID is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Richmond Pharmaceuticals, 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: 54738-0030-15
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Calcium Carbonate

Product Information

NDC	54738-0030
Product ID	54738-030_5cc88da4-0292-200b-e053-2a91aa0ab317
Associated GPIs	48300010000510
GCN Sequence Number	002689
GCN Sequence Number Description	calcium carbonate TAB CHEW 200(500)MG ORAL
HIC3	D4B
HIC3 Description	ANTACIDS
GCN	07893
HICL Sequence Number	001163
HICL Sequence Number Description	CALCIUM CARBONATE
Brand/Generic	Generic
Proprietary Name	ANTACID
Proprietary Name Suffix	n/a
Non-Proprietary Name	Calcium Carbonate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	500
Active Ingredient Units	mg/1
Substance Name	CALCIUM CARBONATE
Labeler Name	Richmond Pharmaceuticals, 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 54738-0030-15 (54738003015)

Pricing Information	N/A
NDC Package Code	54738-030-15
Billing NDC	54738003015
Package	150 TABLET, CHEWABLE in 1 BOTTLE (54738-030-15)
Marketing Start Date	2015-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bc9467ac-4688-401b-af4b-a892c783921d Details

Active Ingredient

(in each tablet)

Calcium Carbonate 500 mg

Purpose

Antacid

Uses

relieves

acid indigestion
heartburn
sour stomach

Warnings

Ask a doctor before use if you have

kidney stones
a calcium-restricted diet
ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if symptoms last more than 2 weeks.

Keep out of reach of children.

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

Directions

chew 1-2 tablets as symptoms occurs.
do not take more than 8 tablets in 24 hours
do not use the maximum dosage for more than 2 weeks

Other Information

each tablet contains: calcium 200 mg
store at room temperature 15-30 °C (59-86 °F)

Inactive Ingredients

Al-lakes (D&C red #27, D&C yellow # 10, FD&C blue #1, FD&C yellow # 6), dextrose, flavors (cherry, lemon, lime, orange), magnesium stearate, maltodextrin

Questions or Comments

Call 804-270-4498, Monday-Friday, 8.30 am – 4.30 pm ET

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calcium Carbonate 500 mg

Antacid tablets

NDC: 54738-030-15 – 150 COUNT

NDC: 54738-030-60 – 60 COUNT

INGREDIENTS AND APPEARANCE

ANTACID

calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54738-030
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	500 mg

Ingredient Name	Strength
Inactive Ingredients
DEXTROSE (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CHERRY (UNII: BUC5I9595W)

Product Characteristics
Color	yellow, pink, green	Score	no score
Shape	ROUND	Size	16mm
Flavor	LIME (Cherry,Lemon,Orange)	Imprint Code	AP;043
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54738-030-15	150 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2015
2	NDC:54738-030-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	05/01/2015

Labeler - Richmond Pharmaceuticals, Inc. (043569607)

Registrant - Advance Pharmaceutical Inc. (078301063)

Name	Address	ID/FEI	Business Operations
Establishment
Advance Pharmaceutical Inc.		078301063	manufacture(54738-030)

Revised: 10/2017

Document Id: 5cc88da4-0292-200b-e053-2a91aa0ab317

Set id: bc9467ac-4688-401b-af4b-a892c783921d

Version: 3

Effective Time: 20171030