ANTACID- calcium carbonate tablet

ANTACID by

Drug Labeling and Warnings

ANTACID by is a Otc medication manufactured, distributed, or labeled by Advance Pharmaceutical 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 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.

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

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 260 mg
• store at room temperature 15-30 °C (59-86 °F)
• For 1000 Count: This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP.

Inactive Ingredients

Croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid

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

Manufactured by: Advance Pharmaceutical Inc. Holtsville, NY 11742

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calcium Carbonate 10 gr

Antacid tablets

NDC: 17714-025-01 – 100 COUNT

NDC: 17714-025-10 – 1000 COUNT (THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN)

INGREDIENTS AND APPEARANCE

ANTACID 
calcium carbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17714-025
Route of Administration	ORAL

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

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

Product Characteristics
Color	white (off)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	AP;025
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17714-025-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/06/1990
2	NDC: 17714-025-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/06/1990

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	04/06/1990

Labeler - Advance Pharmaceutical Inc. (078301063)

Registrant - Advance Pharmaceutical Inc. (078301063)

Establishment
Name	Address	ID/FEI	Business Operations
Advance Pharmaceutical Inc.		078301063	manufacture(17714-025)