Premier Value®

Premier Value®
SPL v6
SPL
SPL Set ID e25bf9ca-415b-4a3e-a502-59074308da54
Route
ORAL
Published
Effective Date 2019-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carbonate Ion (1000 mg) Dimethicone (60 mg)
Inactive Ingredients
Adipic Acid D&c Yellow No. 10 Dextrose, Unspecified Form Fd&c Red No. 40 Fd&c Yellow No. 6 Magnesium Stearate Maltodextrin Silicon Dioxide Starch, Corn Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: RP104 Shape: round Color: orange Color: yellow Color: red Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-22

Description

Calcium carbonate 1000 mg Simethicone 60 mg

Purpose

Antacid Antigas


Medication Information

Purpose

Antacid

Antigas

Description

Calcium carbonate 1000 mg Simethicone 60 mg

Uses

relieves:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach due to these symptoms
  • bloating and pressure commonly referred to as gas
Warnings

Do not take more than 8 tablets in 24 hours or use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

Directions
  • adults and children 12 years and older: chew 1 to 2 tablets completely as symptoms occur or as directed by a doctor. Do not swallow tablets whole.
  • do not take more than 8 tablets in 24 hours or use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.
Other Information
  • each tablet contains: calcium 400 mg
  • store at room temperature
  • keep tightly closed and dry
  • avoid freezing
  • do not use if printed inner seal is broken or missing
Inactive Ingredients

adipic acid, D&C Yellow No. 10, dextrose, FD&C Red No. 40, FD&C Yellow No. 6, flavors, magnesium stearate, maltodextrin, silica, starch, sucralose.

Questions Or Comments?

1-866-467-2748

When Using This Product

at maximum dose, constipation may occur.

Stop Use and Ask A Doctor If

symptoms persist for more than 2 weeks.

Active Ingredients (in Each Tablet)

Calcium carbonate 1000 mg

Simethicone 60 mg

Ask A Doctor Before Use If You Have
  • kidney stones
  • a calcium-restricted diet
Package/label Principal Display Panel

Premier Value®

*COMPARE TO THE ACTIVE INGREDIENTS IN MAALOX® ADVANCED MAXIMUM STRENGTH

NDC: 68016-249-00

Antacid & Anti-Gas

MAXIMUM STRENGTH

Fast relief of:

  • Heartburn
  • Acid indigestion
  • Pressure & bloating
  •  
    Assorted Fruit
  •  
    Naturally Artificially Flavored

90 Chewable Tablets

INDEPENDENTLY TESTED PV SATISFACTION GURANTEED

Distributed by:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., the distributor of Maalox® Advanced Maximum Strength.

Ask A Doctor Or Pharmacist Before Use If You Are

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


Structured Label Content

Uses

relieves:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach due to these symptoms
  • bloating and pressure commonly referred to as gas
Purpose

Antacid

Antigas

Warnings

Do not take more than 8 tablets in 24 hours or use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

Directions
  • adults and children 12 years and older: chew 1 to 2 tablets completely as symptoms occur or as directed by a doctor. Do not swallow tablets whole.
  • do not take more than 8 tablets in 24 hours or use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.
Other Information (Other information)
  • each tablet contains: calcium 400 mg
  • store at room temperature
  • keep tightly closed and dry
  • avoid freezing
  • do not use if printed inner seal is broken or missing
Inactive Ingredients (Inactive ingredients)

adipic acid, D&C Yellow No. 10, dextrose, FD&C Red No. 40, FD&C Yellow No. 6, flavors, magnesium stearate, maltodextrin, silica, starch, sucralose.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

When Using This Product (When using this product)

at maximum dose, constipation may occur.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms persist for more than 2 weeks.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Calcium carbonate 1000 mg

Simethicone 60 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • kidney stones
  • a calcium-restricted diet
Package/label Principal Display Panel (Package/Label Principal Display Panel)

Premier Value®

*COMPARE TO THE ACTIVE INGREDIENTS IN MAALOX® ADVANCED MAXIMUM STRENGTH

NDC: 68016-249-00

Antacid & Anti-Gas

MAXIMUM STRENGTH

Fast relief of:

  • Heartburn
  • Acid indigestion
  • Pressure & bloating
  •  
    Assorted Fruit
  •  
    Naturally Artificially Flavored

90 Chewable Tablets

INDEPENDENTLY TESTED PV SATISFACTION GURANTEED

Distributed by:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., the distributor of Maalox® Advanced Maximum Strength.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

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


Advanced Ingredient Data


Raw Label Data

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