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NDC 43353-0958-85 Rugby Calcium Carbonate 10 gr 648 mg/1 Details

Rugby Calcium Carbonate 10 gr 648 mg/1

Rugby Calcium Carbonate 10 gr is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is CALCIUM CARBONATE.

Product Information

NDC	43353-0958
Product ID	43353-958_451f0be0-8e23-4426-a62f-73540f6f2d73
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	Rugby Calcium Carbonate 10 gr
Proprietary Name Suffix	n/a
Non-Proprietary Name	Antacid Tablets
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	648
Active Ingredient Units	mg/1
Substance Name	CALCIUM CARBONATE
Labeler Name	Aphena Pharma Solutions - Tennessee, LLC
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 43353-0958-85 (43353095885)

Pricing Information	N/A
NDC Package Code	43353-958-85
Billing NDC	43353095885
Package	200 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43353-958-85)
Marketing Start Date	2014-07-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1a92abe8-8310-4ac2-92fe-27dd72ccce50 Details

Active ingredient

Calcium carbonate 10 gr (648 mg)

Purpose

Antacid

Uses

Relieves:

acid indigestion
heartburn
sour stomach
acid indigestion
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.

Stop use and ask a doctor is 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 2 weeks

Other Information

each tablet contains: calcium 260mg

store at room temperature 150-300C (590-860F)

Inactive ingredients

corn starch, crospovidone, magnesium stearate, maltodextrin

Questions or comments

1-800-645-2158

Repackaging Information

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	648mg
30	43353-958-30
60	43353-958-53
90	43353-958-60
100	43353-958-65
180	43353-958-80
200	43353-958-85
270	43353-958-92

Store between 15°-30°C (59°-86°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

20160606DH

PRINCIPAL DISPLAY PANEL - 648mg

NDC 43353-958 - Calcium Carbonate 648mg - Rx Only

INGREDIENTS AND APPEARANCE

RUGBY CALCIUM CARBONATE 10 GR

antacid tablets tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43353-958(NDC:0536-1024)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	RP106
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43353-958-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/02/2014
2	NDC:43353-958-53	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2014
3	NDC:43353-958-60	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2014
4	NDC:43353-958-65	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/26/2014
5	NDC:43353-958-80	180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2014
6	NDC:43353-958-85	200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/29/2014
7	NDC:43353-958-92	270 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	02/07/2014

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

Name	Address	ID/FEI	Business Operations
Establishment
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(43353-958)

Revised: 6/2016

Document Id: 451f0be0-8e23-4426-a62f-73540f6f2d73

Set id: 1a92abe8-8310-4ac2-92fe-27dd72ccce50

Version: 2

Effective Time: 20160606