FDA.reportPublic FDA data

Sunmark Extra Strength Antacid Assorted Fruit Chewable Tablets

Manufacturer
Strategic Sourcing Services LLC | Guardian Drug Company
Effective date
2024-12-13
Label type
Human OTC Drug Label
Version
6
Source
full-release
Hydrated at
2026-06-01 00:43:23

Label at a glance#

ProductSunmark Extra Strength Antacid Assorted Fruit
Active ingredientCALCIUM CARBONATE
Label structure12 sections

Indications and uses

relieves: acid indigestion heartburn

Dosage and administration

adults and children 12 years of age and over: wet in mouth before chewing chew 2-4 tablets as symptoms occur, or as directed by a doctor.

Storage and handling

each tablet contains: elemental calcium 300 mg, magnesium 10 mg do not use if printed seal under cap is torn or missing.  store below 30˚C (86˚F).

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 750 mg

PURPOSE

OTC - PURPOSE SECTION

Antacid

USES

INDICATIONS & USAGE SECTION

relieves:

  • acid indigestion
  • heartburn

WARNINGS

WARNINGS SECTION

.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

OTC - ASK DOCTOR/PHARMACIST SECTION

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

do not take more than 10 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

IF PREGNANT/OR BREASTFEEDING,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and over:
  • wet in mouth before chewing
  • chew 2-4 tablets as symptoms occur, or as directed by a doctor.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • each tablet contains: elemental calcium 300 mg, magnesium 10 mg
  • do not use if printed seal under cap is torn or missing. 
  • store below 30˚C (86˚F).

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

adipic acid, corn starch, crospovidone, D&C red 27 lake, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunmark
COMPARE TO TUMS® E-X ACTIVE INGREDIENT*
NDC 70677-0065-1

antacid tablets Extra Strength
Calcium Carbonate 750 mg

Fast Relief of heartburn & acid indigestion 
ASSORTED FRUIT 

96 CHEWABLE TABLETS

127AF-96-Sunmark127AF-96-Sunmark

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN6
308915calcium carbonate 750 MG Chewable TabletSCD6
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY6

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
70677-0065-1Sunmark Extra Strength Antacid Assorted Fruit96 in 1 BOTTLETABLET, CHEWABLE966

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0065SUNMARK EXTRA STRENGTH ANTACID ASSORTED FRUIT (CALCIUM CARBONATE) TABLET, CHEWABLE [STRATEGIC SOURCING SERVICES LLC]6Legacy NDC, 1 package rows20241215_90d1d48d-21ff-44c4-8da4-e8dea75964d2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0065-1EA - Each70677-0065fb848219-3349-409d-9f76-8d2d8332dd1012022-06-06

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-006570677-0065-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
ADIPIC ACID76A0JE0FKJIACT
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE2S7830E561IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
D&C RED NO. 272LRS185U6KIACT
D&C RED NO. 302S42T2808BIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT

Source Document#

Source XML · Source PDF

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
b446d099-701d-4466-9918-9c853cd50c8c90d1d48d-21ff-44c4-8da4-e8dea75964d22024-12-13WarningsExact identifier
spl id: b446d099-701d-4466-9918-9c853cd50c8c
spl set id: 90d1d48d-21ff-44c4-8da4-e8dea75964d2

Reported adverse events (FAERS/openFDA)#

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