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| Product NDC Code | 53345-009 | ||||
|---|---|---|---|---|---|
| Drug Name | Simethicone |
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| Type | Generic | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 198852 | ||||
| Application Number | part332 | ||||
| Labeler Name | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | ||||
| Packages |
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Overdosage of Simethicone
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of overdose, get medical help or contact a Poison Control Center right away.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each capsule) 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: swallow with water 1 or 2 softgels as needed after meals or at bedtime do not exceed 4 softgels per day unless directed by doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide and white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan, Hubei 430206, China
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 for relief of: bloating pressure fullness stuffed feeling commonly referred to as gas
Purpose
Information about the drug product’s indications for use.Purpose Antiflatulent
Spl product data elements
Usually a list of ingredients in a drug product.Simethicone Simethicone DIMETHICONE DIMETHICONE SILICON DIOXIDE FD&C BLUE NO. 1 FD&C RED NO. 40 D&C YELLOW NO. 10 GELATIN GLYCERIN PEPPERMINT OIL TITANIUM DIOXIDE WATER OVAL PC2
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 - Shipping Label SIMETHICONE CAPSULES, 125 mg Quantity : 25000 Capsules NDC. No : 53345-009-01 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING" Shipping Label
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.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if condition persists.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health care professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at controlled room temperature 15°-30°C (59°-86°F) protect from heat and moisture do not use if imprinted safety seal under cap is broken or missing
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 Stop use and ask a doctor if condition persists. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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