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NDC 71610-0301-65 Calcium Carbonate 10 gr (648 mg) 648 mg/1 Details

Calcium Carbonate 10 gr (648 mg) 648 mg/1

Calcium Carbonate 10 gr (648 mg) is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. 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: 71610-0301-65
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Calcium Carbonate

Product Information

NDC	71610-0301
Product ID	71610-301_1115445c-a777-44ea-8a2c-660293e4d544
Associated GPIs	48300010000309
GCN Sequence Number	059510
GCN Sequence Number Description	calcium carbonate TABLET 260MG(648) ORAL
HIC3	D4B
HIC3 Description	ANTACIDS
GCN	25203
HICL Sequence Number	001163
HICL Sequence Number Description	CALCIUM CARBONATE
Brand/Generic	Generic
Proprietary Name	Calcium Carbonate 10 gr (648 mg)
Proprietary Name Suffix	(Antacid)
Non-Proprietary Name	Calcium Carbonate 10gr (648 mg)
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	648
Active Ingredient Units	mg/1
Substance Name	CALCIUM CARBONATE
Labeler Name	Aphena Pharma Solutions - Tennessee, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part331
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71610-0301-65 (71610030165)

Pricing Information	N/A
NDC Package Code	71610-301-65
Billing NDC	71610030165
Package	100 TABLET in 1 BOTTLE, PLASTIC (71610-301-65)
Marketing Start Date	2019-07-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ac839363-94fd-4c60-b5b6-70e4488ce1dd Details

Active ingredient (in each tablet)

Calcium Carbonate 10 gr (648 mg)

Purpose

Antacid

Uses

relieves

acid indigestion
heartburn
sour stomach
upset stomach associated with these symptoms

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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

take one to four tablets daily
do not take more than 4 tablets in 24 hours
do not use the maximum dosage for more than two weeks

Other information

each tablet contains: calcium 260 mg
store at room temperature

Inactive ingredients

acacia, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid

Questions or comments?

1-800-645-2158

SPL UNCLASSIFIED SECTION

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

This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count	648 mg
180	71610-301-80

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20190711JH

PRINCIPAL DISPLAY PANEL - 648 mg

NDC 71610-301 - Calcium Carbonate 648 mg Tablets

INGREDIENTS AND APPEARANCE

CALCIUM CARBONATE 10 GR (648 MG) (ANTACID)

calcium carbonate 10gr (648 mg) tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71610-301(NDC:0536-1206)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	648 mg

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	PH046
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71610-301-60	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/31/2019
2	NDC:71610-301-65	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/16/2019
3	NDC:71610-301-80	180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/10/2019
4	NDC:71610-301-92	270 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	02/28/2019

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Name	Address	ID/FEI	Business Operations
Establishment
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-301)

Revised: 7/2019

Document Id: 1115445c-a777-44ea-8a2c-660293e4d544

Set id: ac839363-94fd-4c60-b5b6-70e4488ce1dd

Version: 1

Effective Time: 20190711