CALCIUM CARBONATE 500 MG- calcium carbonate tablet, chewable

Calcium Carbonate 500 mg by

Drug Labeling and Warnings

Calcium Carbonate 500 mg by is a Otc medication manufactured, distributed, or labeled by Reliable 1 Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each chewable tablet)

Calcium carbonate 500 mg

Purpose

Antacid

INDICATIONS & USAGE

Uses relieves

• acid indigestion
• heartburn
• sour stomach

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 if symptoms last more than 2 weeks

Keep out of reach of children.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

STOP USE

Stop use and ask doctor if symptoms last more than 2 weeks

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Directions

Adults and children 12 years and over:

• chew 2-4 tablets as symptoms occur
• do not take more than 8 tablets in 24 hours
• do not use the maximum dosage for more than 2 weeks

children under 12 years:

ask a doctor

Other information

• each tablet contains: calcium 200 mg
• store at room temperature

Inactive ingredients

Al-lakes (D&C red #27, D&C yellow #10, FD&C blue #1, FD&C yellow #6), dextrose, flavors, magnesium stearate, maltodextrin

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday-Friday

PRINCIPAL DISPLAY PANEL

NDC: 69618-020-15 *Compare to Active Ingredient of Tums® Regular Strength

ASSORTED FLAVORS

Calcium Carbonate

500 mg

ANTACID

150 CHEWABLE TABLETS

*Reliable-1 Laboratories LLC is not affiliated with the owner of the trademark Tums®

INGREDIENTS AND APPEARANCE

CALCIUM CARBONATE 500 MG 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69618-020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	500 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DEXTROSE (UNII: IY9XDZ35W2)

Product Characteristics
Color	blue (Light Blue) , orange (Light Orange) , yellow (Light Yellow) , purple (Light Purple)	Score	no score
Shape	ROUND	Size	16mm
Flavor	ORANGE (assorted fruit)	Imprint Code	AP;043
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69618-020-15	150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	11/01/2015

Labeler - Reliable 1 Laboratories LLC (079718111)