Major Regular Strength Antacid 150 Chewable Tablets

Manufacturer
REMEDYREPACK INC.
Effective date
2022-06-16
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:59:09

Label at a glance#

ProductMajor Regular Strength Assorted Flavors
Active ingredientCALCIUM CARBONATE
Label structure8 sections

Indications and uses

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

Dosage and administration

Adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor. Do not swallow tablets whole, Do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate USP 500mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves:

• heartburn

• sour stomach

• acid indigestion

• upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

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

When using this product

  • do not take more than 15 tablets in 24 hours
  • If pregnant do not take more than 10 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor.
  • Do not swallow tablets whole,
  • Do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.

Other Information

SPL UNCLASSIFIED SECTION

  • Each tablet contains: elemental calcium 200 mg
  • Store at room temperature. Keep the container tightly closed

Safety sealed: Do not use if printed seal under cap is torn or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

adipic acid, D&C Red No. 27 lake, D&C Yellow No. 10 lake, dextrose, FD&C Blue No. 1 lake, FD&C Yellow No. 6 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Major Regular StrengthAssorted Flavors Assorted Flavors

GENERIC: Antacid Tablets

DOSAGE: TABLET, CHEWABLE

ADMINSTRATION: ORAL

NDC: 70518-0415-0

NDC: 70518-0415-1

NDC: 70518-0415-2

COLOR: white

FLAVOR: FRUIT

SHAPE: ROUND

SCORE: No score

SIZE: 16 mm

IMPRINT: RP101

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 30 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

  • CALCIUM CARBONATE 500mg in 1

INACTIVE INGREDIENT(S):

  • ADIPIC ACID
  • D&C RED NO. 27
  • D&C YELLOW NO. 10
  • DEXTROSE, UNSPECIFIED FORM
  • FD&C BLUE NO. 1
  • FD&C YELLOW NO. 6
  • MAGNESIUM STEARATE
  • MALTODEXTRIN
  • STARCH, CORN
  • SUCRALOSE

MM1MM1

MM2MM2

MM3MM3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6412-92EA - Each0904-6412bb975321-582f-4b0a-b5a6-7010bc851aaa12014-12-01

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
70518-041570518-0415-0, 70518-0415-2, 70518-0415-1
0904-6412

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
Major Regular Strength Assorted FlavorsANTACID TABLETSMajor Pharmaceuticals2ba0eeb2-7048-4259-83d5-9f4ec1c92d322026-07-13WarningsExact identifier
ndc (product): 0904-6412
e7b3d160-d995-e67e-e053-2a95a90a34b26db9b523-2be6-4667-b9f9-ea9b8be607fd2022-09-02WarningsExact identifier
spl set id: 6db9b523-2be6-4667-b9f9-ea9b8be607fd

Reported adverse events (FAERS/openFDA)#

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