D-Cal Kids: Package Insert and Label Information

D-CAL KIDS- calcium carbonate granule
A&Z Pharmaceutical, Inc.

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

Calcium Carbonate 750 mg (in each pouch)

Purpose

Antacid

Uses

Relieves:

• Heartburn
• Acid indigestion
• Sour stomach
• Upset stomach due to these symptoms

Warnings

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product:

• do not take more than 1 pouch in a 24 hour period.
• use open pouch within two weeks.

Keep Out of Reach of Children

Directions

• Find the right dose on chart below based on weight, otherwise use age.
• Pour powder into cup and add 15mg (0.51 oz.) of water, stir and drink.

Dosing Chart

Weight (lbs)	Age	Dose
Under 24	Under 2 yrs	Ask a doctor
24-47	2-5 yrs	1/2 pouch
48-95	6-11 yrs	1 pouch

Inactive ingredients

Cholecalciferol, dextrose, maltodextrin, sodium citrate

Other Information

Store in a dry place.

Do not use if pouch is open or torn.

Mfg by: A&Z Pharmaceutical, Inc.

Hauppauge, NY 11788

Call toll free 1-800-480-1059 Monday through Friday 9AM-5PM

Principal Display Panel — Carton Label

D-Cal® Kids Granules

Calcium Supplement

Antacid

10 pouches

Principal Display Panel — Pouch Front Label

Principal Display Panel — Pouch Back Label

D-CAL KIDS calcium carbonate granule

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62211-239 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (CALCIUM CATION and CARBONATE ION) CALCIUM CARBONATE 750 mg in 1 g

Inactive Ingredients Ingredient Name Strength CHOLECALCIFEROL DEXTROSE MALTODEXTRIN SODIUM CITRATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62211-239-57 10 POUCH in 1 BOX contains a POUCH 1 1 g in 1 POUCH This package is contained within the BOX (62211-239-57)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 01/04/2008

Labeler — A&Z Pharmaceutical, Inc. (080225262)

Registrant — A&Z Pharmaceutical, Inc. (080225262)

Establishment
Name	Address	ID/FEI	Operations
A&Z Pharmaceutical, Inc.		080225262	manufacture (62211-239)

Revised: 10/2019 A&Z Pharmaceutical, Inc.