RUGBY CALCIUM CARBONATE 10 GR- antacid tablets tablet, chewable 
Aphena Pharma Solutions - Tennessee, LLC

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.

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Drug Facts

Active ingredient

Calcium carbonate 10 gr (648 mg)

Purpose

Antacid

Uses

Relieves:

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

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:

Count648mg
3043353-958-30
6043353-958-53
9043353-958-60
10043353-958-65
18043353-958-80
20043353-958-85
27043353-958-92

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:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20160606DH

PRINCIPAL DISPLAY PANEL - 648mg

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

RUGBY CALCIUM CARBONATE 10 GR 
antacid tablets tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43353-958(NDC:0536-1024)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE648 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code RP106
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43353-958-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/02/2014
2NDC:43353-958-5360 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2014
3NDC:43353-958-6090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2014
4NDC:43353-958-65100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/26/2014
5NDC:43353-958-80180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2014
6NDC:43353-958-85200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2014
7NDC:43353-958-92270 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33102/07/2014
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(43353-958)

Revised: 6/2016
Document Id: 451f0be0-8e23-4426-a62f-73540f6f2d73
Set id: 1a92abe8-8310-4ac2-92fe-27dd72ccce50
Version: 2
Effective Time: 20160606
 
Aphena Pharma Solutions - Tennessee, LLC