Rugby Calcium Carbonate 10 Gr (Antacid Tablets) Tablet, Chewable [Aphena Pharma Solutions

RUGBY CALCIUM CARBONATE 10 GR (ANTACID TABLETS) TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]
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NDC	43353-958-30, 43353-958-53, 43353-958-60, 43353-958-65, 43353-958-80, 43353-958-85, 43353-958-92
Set ID	1a92abe8-8310-4ac2-92fe-27dd72ccce50
Category	HUMAN OTC DRUG LABEL
Packager	Aphena Pharma Solutions - Tennessee, LLC
Generic Name
Product Class
Product Number
Application Number	PART331

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	648 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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