D-Cal Kids: Package Insert and Label Information

D-CAL KIDS- calcium carbonate tablet, chewable
AiPing 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 INGREDIENTS

Calcium Carbonate 750 mg

PURPOSES

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 5 tablets in a 24 hour period. Keep out of reach of children.

Keep out of reach of children

Directions

  • chew one tablet daily. If symptoms persist, ask a doctor.

Other Information

  • store in a dry place
  • do not use if imprinted seal under cap is torn or open

Inactive ingredients

cholecalciferol, aspartame, citric acid, D&C Yellow #6, FD&C Blue #1, FD&C Red #40, FD&C Yellow #5, FD&C Yellow #10, flavors, magnesium stearate, sorbitol

PRINCIPAL DISPLAY PANEL

0021
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D-CAL KIDS
calcium carbonate tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11788-021
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
Inactive Ingredients
Ingredient Name Strength
CHOLECALCIFEROL
ASPARTAME
CITRIC ACID MONOHYDRATE
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
MAGNESIUM STEARATE
SORBITOL
Product Characteristics
Color orange Score no score
Shape FREEFORM Size 17mm
Flavor Imprint Code 0
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11788-021-03 30 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 09/17/1997
Labeler — AiPing Pharmaceutical, Inc. (079674526)
Registrant — AiPing Pharmaceutical, Inc. (079674526)
Establishment
Name Address ID/FEI Operations
A&Z Pharmaceutical, Inc. 080225262 manufacture (11788-021)

Revised: 08/2022 AiPing Pharmaceutical, Inc.

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