FDA.reportPublic FDA data

CVS Orange Cream Antacid Chews

Manufacturer
CVS Pharmacy | Bestco
Effective date
2025-12-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:23:36

Label at a glance#

ProductCVS Orange Cream Antacid Chews
Active ingredientCALCIUM CARBONATE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each chewable tablet)

Calcium carbonate 750 mg

OTC - PURPOSE SECTION

Purpose

Antacid

INDICATIONS & USAGE SECTION

Uses Relieves

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

WARNINGS SECTION

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Do not take more 5 chewable tablets in a 24-hour period, or use the maximum dosage for this product for more than 2 weeks, except under the advice and supervision of a physician.

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product constipation may occur

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 12 years and older chew and swallow 1 to 2 chewable tablets every 2-4 hours as needed.

Children under 12 years consult a doctor.

OTHER SAFETY INFORMATION

Other information

  • Each chewable tablet contains: calcium 300 mg
  • Contains soy
  • Contains FD&C yellow No. 5 (tartrazine) as a color additive
  • Store between 20° to 25°C (68° to 77°F) in a dry place

INACTIVE INGREDIENT SECTION

Inactive ingredients: Beeswax, carnauba wax, citric acid, corn starch, corn syrup, dextrin, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6, FD&C yellow no. 6 aluminum lake, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, methylparaben, natural and artificial flavors, phosphoric acid, pregelantinized corn starch, propylene glycol, propylparaben, purified water, shellac, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose, titanium dioxide.

OTC - QUESTIONS SECTION

Questions? Or to report an adverse event call 1-800-245-2898 Monday - Friday, 9AM - 4PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Orange Cream Antacid Chews 60ctCVS Orange Cream Antacid Chews 60ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN1
308915calcium carbonate 750 MG Chewable TabletSCD1
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-085-60CVS Orange Cream Antacid Chews60 in 1 BOTTLETABLET, CHEWABLE601

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-08551316-085-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
CALCIUM CARBONATEH0G9379FGKACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Orange Cream Antacid ChewsCALCIUM CARBONATECVS Pharmacy45f6b593-a09c-ce0b-e063-6394a90ae3072025-12-14WarningsExact identifier
ndc (package): 51316-085-60
ndc (product): 51316-085
ndc11 (package): 51316008560
spl id: 45f6b593-a09d-ce0b-e063-6394a90ae307
spl set id: 45f6b593-a09c-ce0b-e063-6394a90ae307

Reported adverse events (FAERS/openFDA)#

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