MAJOR REGULAR STRENGTH ASSORTED FLAVORS- antacid tablets tablet, chewable 
REMEDYREPACK 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.

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Major Regular Strength Antacid 150 Chewable Tablets

Active ingredient

Calcium Carbonate USP 500mg

Purpose

Antacid

Uses

relieves:

• heartburn

• sour stomach

• acid indigestion

• upset stomach associated with these symptoms

Warnings

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.

Keep out of Reach of Children

Directions

  • 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

  • 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

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.

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

MM1

MM2

MM3

MAJOR REGULAR STRENGTH  ASSORTED FLAVORS
antacid tablets tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0415(NDC:0904-6412)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE500 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ADIPIC ACID (UNII: 76A0JE0FKJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize16mm
FlavorFRUITImprint Code RP101
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-0415-030 in 1 BLISTER PACK; Type 0: Not a Combination Product04/10/201701/06/2021
2NDC:70518-0415-130 in 1 BOX04/15/201905/06/2019
2NDC:70518-0415-21 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33104/10/201701/06/2021
Labeler - REMEDYREPACK INC. (829572556)

Revised: 9/2022
 
REMEDYREPACK INC.