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Product NDC Code | 82431-201 | ||||||
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Drug Name | Wonderbelly extra strength anti-gas |
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Type | Brand | ||||||
Pharm Class | Skin Barrier Activity [PE] | ||||||
Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | TABLET, CHEWABLE | ||||||
RxCUI drug identifier | 314221 | ||||||
Application Number | M002 | ||||||
Labeler Name | Ginger Health Company | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Section 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 Adults and children 12 years of age and older: Chew 1-2 tablets as symptoms occur, or as directed by a doctor. Chew or crush tablets completely before swallowing. Do not take more than 4 tablets in a 24-hour period except under the advice and supervision of a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients calcium carbonate, calcium phosphate, sucrose, maltodextrin, natural flavors, silicon dixoide, starch, vegetable magnesium stearate
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.Uses Uses Relieves Pressure Bloating Fullness commonly 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.Wonderbelly Extra Strength Anti-Gas Simethicone DIMETHICONE DIMETHICONE CALCIUM CARBONATE TRIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE STARCH, CORN DIBASIC CALCIUM PHOSPHATE DIHYDRATE MAGNESIUM STEARATE MALTODEXTRIN SUCROSE Shortcake Rounded Corners W;201
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-SS 42ct UC Rev 0624 SS 42ct REV 0624
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Each tablet contains: calcium 218mg. Store at room temperature and keep container tightly closed.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professsional before use.
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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
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