MAJOR REGULAR STRENGTH ASSORTED FLAVORS- antacid tablets tablet, chewable

Major Regular Strength by

Drug Labeling and Warnings

Major Regular Strength by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

do not use the maximum dosage for more than 2 weeks.

Keep out of Reach of Children

Directions

Chew 2-4 tablets as symptoms occur, or as directed by a doctor.

Other Information

Store below 30°C (86°F).

Keep the container tightly closed

For calcium and magnesium content see Supplement Facts.

Inactive ingredients

adipic acid, blue 1 aluminum lake, dextrose, flavors, magnesium stearate, maltodextrin, red 27 aluminum lake, starch, sucralose, yellow 6 aluminum lake, yellow 10 aluminum lake.

CALCIUM SUPPLEMENT

USES: As a daily source of extra calcium.

DIRECTIONS: Chew 2 tablets once or twice daily with a meal

Supplement Facts

Serving Size: 2 Tablets

Servings Per Container: 75

• Amount Per Serving %:

  Daily Value

• Calcium 400mg:

  40%

• Magnesium 2mg:

  less than 1%

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

INGREDIENTS AND APPEARANCE

MAJOR REGULAR STRENGTH  ASSORTED FLAVORS
antacid tablets tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-0415(NDC:0904-6412)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	500 mg

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID (UNII: 76A0JE0FKJ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
DEXTROSE (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	16mm
Flavor	FRUIT	Imprint Code	RP101
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-0415-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/10/2017
2	NDC: 70518-0415-1	30 in 1 BOX	04/15/2019
2	NDC: 70518-0415-2	1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	04/10/2017

Labeler - REMEDYREPACK INC. (829572556)