Label: RUGBY CALCIUM CARBONATE 10 GR- antacid tablets tablet, chewable
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NDC Code(s):
43353-958-30,
43353-958-53,
43353-958-60,
43353-958-65, view more43353-958-80, 43353-958-85, 43353-958-92
- Packager: Aphena Pharma Solutions - Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 0536-1024
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 6, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other Information
- Inactive ingredients
- Questions or comments
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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
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INGREDIENTS AND APPEARANCE
RUGBY CALCIUM CARBONATE 10 GR
antacid tablets tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43353-958(NDC:0536-1024) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 648 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 02/07/2014 Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(43353-958)
