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NDC 70518-2265-00 Calcium Carbonate 1250 mg/5mL Details

Calcium Carbonate 1250 mg/5mL

Calcium Carbonate is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by REMEDYREPACK 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: 70518-2265-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Calcium Carbonate

Product Information

NDC	70518-2265
Product ID	70518-2265_db104201-2662-48a2-e053-2a95a90aa23a
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Calcium Carbonate
Proprietary Name Suffix	n/a
Non-Proprietary Name	Calcium Carbonate
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	1250
Active Ingredient Units	mg/5mL
Substance Name	CALCIUM CARBONATE
Labeler Name	REMEDYREPACK 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	2023-12-31

Package

Package Images

NDC 70518-2265-00 (70518226500)

Pricing Information	N/A
NDC Package Code	70518-2265-0
Billing NDC	70518226500
Package	10 CUP, UNIT-DOSE in 1 BOX (70518-2265-0) / 5 mL in 1 CUP, UNIT-DOSE (70518-2265-1)
Marketing Start Date	2019-08-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 645c1e53-aa8b-4a57-9184-77e5a2b9bd6c Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Calcium Carbonate 1250 mg

(Equivalent to 500 mg elemental Calcium)

Purpose

Antacid

Uses

Relieves:

heartburn
acid indigestion
sour stomach
upset stomach associated with these symptoms

Warnings

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product, do not take more than 6 teaspoonfuls (30 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks.

Keep out of reach of children.

Directions

Shake well before using.
Take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor.

Other information

store at 20° - 25°C (68° - 77°F)
do not freeze
Calcium Carbonate Oral Suspension is a pink-colored, bubble gum flavored suspension supplied in the following oral dosage forms:

NDC 0121-0766-16:	16 fl oz (473 mL) bottle
NDC 0121-4766-05:	5 mL unit dose cup, in a tray of ten cups.

Inactive ingredients

calcium saccharin, citric acid, D&C Red No. 33, FD&C Red No. 40, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol and xanthan gum.

Questions or comments?

Call 1-800-845-8210.

You may also report serious side effects to this phone number.

SPL UNCLASSIFIED SECTION

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PRINCIPAL DISPLAY PANEL

DRUG: Calcium Carbonate

GENERIC: Calcium Carbonate

DOSAGE: SUSPENSION

ADMINSTRATION: ORAL

NDC: 70518-2265-0

NDC: 70518-2265-1

COLOR: pink

FLAVOR: BUBBLE GUM

PACKAGING: 5 mL in 1 CUP, UNIT-DOSE

OUTER PACKAGING: 10 in 1 BOX

ACTIVE INGREDIENT(S):

CALCIUM CARBONATE 1250mg in 5mL

INACTIVE INGREDIENT(S):

PROPYLPARABEN
METHYLPARABEN
PROPYLENE GLYCOL
SORBITOL
GLYCERIN
XANTHAN GUM
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
D&C RED NO. 33
SACCHARIN CALCIUM
WATER

INGREDIENTS AND APPEARANCE

CALCIUM CARBONATE

calcium carbonate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-2265(NDC:0121-0766)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	1250 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SACCHARIN CALCIUM (UNII: 5101OP7P2I)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70518-2265-0	10 in 1 BOX	08/16/2019
1	NDC:70518-2265-1	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	08/16/2019

Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2022

Document Id: db104201-2662-48a2-e053-2a95a90aa23a

Set id: 645c1e53-aa8b-4a57-9184-77e5a2b9bd6c

Version: 3

Effective Time: 20220325

Search by Drug Name or NDC

NDC 70518-2265-00 Calcium Carbonate 1250 mg/5mL Details

Calcium Carbonate 1250 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 70518-2265-00 (70518226500)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 645c1e53-aa8b-4a57-9184-77e5a2b9bd6c Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each 5 mL teaspoonful)

Purpose

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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