OTC Medication Information: Rugby Calcium Carbonate 10 Gr

RUGBY CALCIUM CARBONATE 10 GR- calcium carbonate 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.

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 -300 C (590 -860 F)

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
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 648 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MAGNESIUM STEARATE
MALTODEXTRIN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code RP106
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43353-958-30 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC None
2 NDC:43353-958-53 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC None
3 NDC:43353-958-60 90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC None
4 NDC:43353-958-65 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC None
5 NDC:43353-958-80 180 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC None
6 NDC:43353-958-85 200 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC None
7 NDC:43353-958-92 270 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC None
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 Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (43353-958)

Revised: 06/2016 Aphena Pharma Solutions — Tennessee, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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