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:

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

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