MAGNACAL- calcium carbonate tablet, chewable

Magnacal by

Drug Labeling and Warnings

Magnacal by is a Otc medication manufactured, distributed, or labeled by Afassco Inc., ULTRAtab Laboratories, Inc., ULTRA SEAL CORPORATION, ULTRATAB LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT IN EACH TABLET- CALCIUM CARBONATE 420 MG

PURPOSE

ANTACID

INDICATIONS & USAGE

Uses: For the relief of the following symptoms associated with:

acid indigestion sour stomach

heartburn upset stomach

WARNINGS

Warnings:

Ask a doctor or health professional before use if you are:

taking a prescription drug. Antacids may interact with certain prescription drugs.

do not use a maximum dosage for more than 2 weeks except under the advice of a physician.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding baby, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions:

Adults and children: (12 years and older) 2 or more tablets chewed not to exceed18 tablets in a 24 hour period

Children: (under 12 years) Do not give to children under 12 years of age unless directed by a doctor.

INACTIVE INGREDIENT

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

OTHER SAFETY INFORMATION

Other Information:

Each tablet contains: 168 mg of elemental calcium.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

MAGNACAL 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51532-0303
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	420

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MINT (UNII: FV98Z8GITP)
ACACIA (UNII: 5C5403N26O)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	white (WHITE)	Score	no score
Shape	ROUND	Size	12mm
Flavor	MINT	Imprint Code	FR8
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51532-0303-2	2 in 1 PACKET; Type 0: Not a Combination Product	10/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	04/07/2015

Labeler - Afassco Inc. (609982723)

Registrant - ULTRAtab Laboratories, Inc. (151051757)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(51532-0303)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRATAB LABORATORIES, INC.		151051757	manufacture(51532-0303)