OTC Medication Information: Calcium Antacidextra Strength Extra Strength

CALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH- calcium carbonate tablet, chewable
Rugby Laboratories

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (per tablet)

Calcium Carbonate USP 750mg

Purpose

Antacid

Uses

relieves

heartburn
sour stomach
acid indigestion
upset stomach associated with these symptoms

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 24 hours
if pregnant do not take more than 6 tablets in 24 hours
do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Keep out of reach of children.

Directions

adults and children 12 years of age and ove r: chew 2 — 4 tablets as symptoms occur, or as directed by a doctor
do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other information

each tablet contains: elemental calcium 300 mg
Store at room temperature. Keep the container tightly closed.

Inactive ingredients

adipic acid, D&C red #27lake, D&C yellow#10 lake, dextrose, FD&C blue #1 lake, FD&C yellow#6 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose

Questions or comments ?

1-800-645-2158

Principal Display Panel

SAFETY SEALED. DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

COMPARE TO the active ingredient of TUMS® EXTRA STRENGTH

NDC 0536-1049-22

Rugby®

CALCIUM

Antacid

Tablets

Extra Strength

Calcium Carbonate 750 mg

ASSORTED FRUIT

Naturally &Artificially Flavored

96 Chewable TABLETS

GLUTEN-FREE

*This product is not manufactured or distributed by GlaxoSmithKline LLC,

Owner of the registered trademark,

Extra Strength Tums®

Distributed by Rugby laboratories

17177 n Laurel Park Drive, Suite 233

Livonia, MI, 48152, USA

www.rugbylaboratories.com

Calcium Antacid Tablets Extra Strength
(click image for full-size original)
CALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH
calcium carbonate tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1049
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CARBONATE (CARBONATE ION) CALCIUM CARBONATE 750 mg
Inactive Ingredients
Ingredient Name Strength
ADIPIC ACID
D&C RED NO. 27
D&C YELLOW NO. 10
DEXTROSE, UNSPECIFIED FORM
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
MALTODEXTRIN
STARCH, CORN
SUCRALOSE
Product Characteristics
Color YELLOW, GREEN, RED, ORANGE Score no score
Shape ROUND Size 17mm
Flavor FRUIT (lemon, orange, cherry, lime) Imprint Code RP102
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0536-1049-22 96 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part331 03/15/2015
Labeler — Rugby Laboratories (079246066)

Revised: 12/2020 Rugby Laboratories

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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