Major Regular Strength Assorted Flavors (Antacid Tablets) Tablet, Chewable [Remedyrepack Inc.] -

MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [REMEDYREPACK INC.]
PDF | XML

NDC	70518-0415-0, 70518-0415-1, 70518-0415-2
Set ID	6db9b523-2be6-4667-b9f9-ea9b8be607fd
Category	HUMAN OTC DRUG LABEL
Packager	REMEDYREPACK INC.
Generic Name
Product Class
Product Number
Application Number	PART331

View All Sections

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.
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

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

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

Ingredient Name	Strength
Inactive Ingredients
ADIPIC ACID (UNII: 76A0JE0FKJ)
D&C RED NO. 27 (UNII: 2LRS185U6K)
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
Color	white	Score	no score
Shape	ROUND	Size	16mm
Flavor	FRUIT	Imprint Code	RP101
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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	05/06/2019
2	NDC:70518-0415-2	1 in 1 POUCH; Type 0: Not a Combination Product

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

Labeler - REMEDYREPACK INC. (829572556)

View All Sections

Medic

MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [REMEDYREPACK INC.]

Related Drugs