RUGBY EXTRA STRENGTH ANTACID- calcium carbonate tablet, chewable

Rugby Extra Strength Antacid by

Drug Labeling and Warnings

Rugby Extra Strength Antacid by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (in each tablet)

Calcium carbonate 750 mg

PURPOSE

Antacid

USE(S)

relieves:

• acid indigestion
• heartburn

WARNINGS

.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

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

WHEN USING THIS PRODUCT

do not take more than 10 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

IF PREGNANT OR/BREASTFEEDING,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

.

DIRECTIONS

• adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor.

OTHER INFORMATION

• each tablet contains: elemental calcium 300 mg
• do not use if printed seal under the cap is torn or missing
• store at room temperature. keep the container tightly closed.

INACTIVE INGREDIENTS

adipic acid, corn starch, crospovidone, dextrose, FD&C blue 1 lake, FD&C red 40 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredient of TUMS® EXTRA STRENGTH*
NDC: 0536-1229-22
Rugby
CALCIUM
Antacid Tablets
Extra Strength 
Calcium Carbonate 750 mg
Assorted Berries
Naturally & Artificially Flavored
96 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

RUGBY EXTRA STRENGTH ANTACID 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1229
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	750 mg

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID (UNII: 76A0JE0FKJ)
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	BLUE, PINK, PINK (PINKISH BLUE)	Score	no score
Shape	ROUND	Size	16mm
Flavor	BERRY (STRAWBERRY, RASPBERRY, WIDBERRY)	Imprint Code	G127
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1229-22	96 in 1 BOTTLE; Type 0: Not a Combination Product	04/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part331	04/14/2019

Labeler - Rugby Laboratories (079246066)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(0536-1229)