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Careone extra strength gas relief - Medication Information

Product NDC Code 72476-019
Drug Name

Careone extra strength gas relief

Type Brand
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 125 mg/1
Route ORAL
Dosage Form TABLET, CHEWABLE
RxCUI drug identifier 314221
Application Number part332
Labeler Name Retail Business Services, LLC.
Packages
Package NDC Code Description
72476-019-73 3 blister pack in 1 carton (72476-019-73) / 6 tablet, chewable in 1 blister pack
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENT(in each tablet) Simethicone 125 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
DIRECTIONS chew 1 to 2 tablets thoroughly as needed after meals and at bedtime do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS D&C red # 30 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
USE(S) relieves: pressure bloating symptoms referred to as gas

Purpose

Information about the drug product’s indications for use.
PURPOSE Anti-gas

Spl product data elements

Usually a list of ingredients in a drug product.
Careone Extra Strength Gas Relief Simethicone DIMETHICONE DIMETHICONE D&C RED NO. 30 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SORBITOL SUCROSE MALTODEXTRIN DEXTROSE, UNSPECIFIED FORM G134

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL NDC 72476-019-73 Careone Compare to the Active Ingredient in Gas-X® Chewables Extra Strength* EXTRA STRENGTH GAS RELIEF Simethicone 125 mg - Anti-Gas Cherry Creme FAST RELIEF OF: DISCOMFORT FROM GAS BLOATING PRESSURE 18 chewable tablets 102

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a poison control center immediately.

Storage and handling

Information about safe storage and handling of the drug product.
OTHER INFORMATION do not use if any individual blister unit is broken or open store at room temperature avoid high humidity and excessive heat, above 40ºC (104ºF)

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
WARNINGS .

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API