CALCIUM CARBONATE 10 GR (648 MG) (ANTACID) (calcium carbonate 10gr- 648 mg tablet

Calcium Carbonate 10 gr (648 mg) by

Drug Labeling and Warnings

Calcium Carbonate 10 gr (648 mg) by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES, Pharbest Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Calcium Carbonate 10 gr (648 mg)

Purpose

Antacid

Uses

relieves

• acid indigestion
• heartburn
• sour stomach
• upset stomach associated with these symptoms

Warnings

Ask a doctor before use if you have

• kidney stones
• a calcium-restricted diet

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 if

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 two weeks

Other information

• each tablet contains: calcium 260 mg
• store at room temperature

Inactive ingredients

acacia, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid

Questions or comments?

1-800-645-2158

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

PRINCIPAL DISPLAY PANEL

NDC: 0536-1206-10

Rugby ®

Calcium

Carbonate

10 gr (648 mg)

ANTACID

1000 TABLETS

INGREDIENTS AND APPEARANCE

CALCIUM CARBONATE 10 GR (648 MG)  (ANTACID)
calcium carbonate 10gr (648 mg) tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1206
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	648 mg

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	PH046
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1206-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	02/28/2019

Labeler - RUGBY LABORATORIES (079246066)

Registrant - Pharbest Pharmaceuticals Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals Inc.		557054835	manufacture(0536-1206) , pack(0536-1206) , label(0536-1206)