RUGBY CALCIUM CARBONATE 10 GR- antacid tablets tablet, chewable

Rugby Calcium Carbonate 10 gr by

Drug Labeling and Warnings

Rugby Calcium Carbonate 10 gr by is a Otc medication manufactured, distributed, or labeled by Aphena Pharma Solutions - Tennessee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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)