FDA.reportPublic FDA data

Calcium Carbonate

Manufacturer
PINNACLE PHARMA LLC
Effective date
2021-07-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:20

Label at a glance#

ProductCalcium Carbonate
Active ingredientCALCIUM CARBONATE
Label structure11 sections

Indications and uses

Relieves: heartburn acid indigestion sour stomach upset stomach associated with these symptoms

Dosage and administration

Shake well before using. Take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor.

Storage and handling

store at 20° - 25°C (68° - 77°F) do not freeze Calcium Carbonate Oral Suspension is a pink-colored, bubble gum flavored suspension supplied in the following oral dosage forms: NDC 0121-0766-16: 16 fl oz (473 mL) bottle NDC 0121-4766-05: 5 mL unit dose cup, in a tray of ten cups.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate 1250 mg
(Equivalent to 500 mg elemental Calcium)

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

Relieves:

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product, do not take more than 6 teaspoonfuls (30 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before using.
  • Take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor.

Other information

STORAGE AND HANDLING SECTION

  • store at 20° - 25°C (68° - 77°F)
  • do not freeze
  • Calcium Carbonate Oral Suspension is a pink-colored, bubble gum flavored suspension supplied in the following oral dosage forms:
NDC 0121-0766-16:16 fl oz (473 mL) bottle
NDC 0121-4766-05:5 mL unit dose cup, in a tray of ten cups.

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium saccharin, citric acid, D&C Red No. 33, FD&C Red No. 40, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol and xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210.

You may also report serious side effects to this phone number.

SPL UNCLASSIFIED SECTION

MANUFACTURED BY

Pharmaceutical Associates, Inc. Greenville, SC 29605

R07/20

PRINCIPAL DISPLAY PANEL - 5 mL Cup Tray Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81646-112-05

Calcium Carbonate Oral
Suspension
Maximum Strength

1250 mg/5 mL
(equivalent to 500 mg of elemental Calcium)

SUGAR FREE/ ALCOHOL FREE/ SODIUM FREE

ANTACID – SHAKE WELL

USUAL DOSAGE: See attached Drug Facts

This unit-dose package is not child-resistant.

Store at 20° - 25°C (68° - 77°F)
10 x 5 mL Unit-Dose Cups

Pinnacle Pharma LLC
Charlotte, NC 28217                    

Case Label
Case Label
Cup Label
Cup Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308891calcium carbonate 1250 MG in 5 mL Oral SuspensionPSN1
308891calcium carbonate 250 MG/ML Oral SuspensionSCD1
308891calcium carbonate 1250 MG (calcium 500 MG) per 5 ML Oral SuspensionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81646-112-052023-01-30C16284748780-1f386c649-ac11-0266-e053-dadaa90a7c1aCalcium Carbonate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81646-112-05Calcium Carbonate05 mL in 1 CUP, UNIT-DOSESUSPENSION051

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81646-112CALCIUM CARBONATE SUSPENSION [PINNACLE PHARMA LLC]1Legacy NDC, 1 package rows20210710_6bf2382e-6f10-4916-8c46-07174c7af0eb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0766-16ML - Milliliter0121-0766a19d6d49-7c07-4740-a670-1066e0d061f512014-11-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81646-11281646-112-05
0121-0766

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
PROPYLPARABENZ8IX2SC1OHIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
D&C RED NO. 339DBA0SBB0LIACT
SACCHARIN CALCIUM5101OP7P2IIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium CarbonateCALCIUM CARBONATEPAI Holdings, LLC dba PAI Pharmad89f3184-7081-4e16-a504-9214283891f62024-11-12WarningsExact identifier
ndc (product): 0121-0766
1c6c35ba-f218-45d2-b6c4-b47b6a2772396bf2382e-6f10-4916-8c46-07174c7af0eb2021-07-08WarningsExact identifier
spl id: 1c6c35ba-f218-45d2-b6c4-b47b6a277239
spl set id: 6bf2382e-6f10-4916-8c46-07174c7af0eb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.