ANTACID- calcium carbonate tablet, chewable

ANTACID by

Drug Labeling and Warnings

ANTACID by is a Otc medication manufactured, distributed, or labeled by Kinray Inc., Advance Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

(in each chewable tablet)

Calcium Carbonate 500 mg

Purpose

Antacid

Uses

relieves

• acid indigestion
• heartburn
• sour stomach

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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• chew 1-2 tablets as symptoms occurs.
• do not take more than 8 tablets in 24 hours
• do not use the maximum dosage for more than 2 weeks

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 (cherry, lemon, lime, orange), magnesium stearate, maltodextrin

Questions or Comments

Call 631-981-4600, Monday-Friday, 8.30 am – 4.30 pm ET

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calcium Carbonate 500 mg

Antacid tablets

NDC: 61715-058-54 – 150 COUNT

INGREDIENTS AND APPEARANCE

ANTACID 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61715-058
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
DEXTROSE (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CHERRY (UNII: BUC5I9595W)
LEMON (UNII: 24RS0A988O)
ORANGE (UNII: 5EVU04N5QU)

Product Characteristics
Color	YELLOW, PINK, GREEN	Score	score with uneven pieces
Shape	ROUND	Size	16mm
Flavor	LIME (Cherry,Lemon,Orange)	Imprint Code	AP;043
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61715-058-54	150 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	06/28/2013

Labeler - Kinray Inc. (012574513)

Registrant - Advance Pharmaceutical Inc. (078301063)

Establishment
Name	Address	ID/FEI	Business Operations
Advance Pharmaceutical Inc.		078301063	MANUFACTURE(61715-058)