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| Product NDC Code | 73513-323 | ||||
|---|---|---|---|---|---|
| Drug Name | Topwin speedy enema |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | RECTAL | ||||
| Dosage Form | ENEMA | ||||
| Application Number | M007 | ||||
| Labeler Name | Health Chemical Pharmaceutical Co., Ltd | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Glycerin 3g
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 Single Daily Usage (per 24 hours) Adults and children, 6 years and over: 20 ml / 3g Glycerin or as directed by a doctor Children 3-6 years: 10 ml / 1.5g Glycerin or as directed by a doctor Knee-chest / Upright position: Lubricate anus with petroleum jelly first, gently insert tip of the enema applicator into the rectum with a single side to side movement to prevent damage to the rectal wall, allow 15 minutes to 1 hour to produce bowel movement. Discard unit after use. No left fluid should be re-used.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Methylparaben, Sodium Chloride, Sodium Benzoate, Water
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 occasional constipation
Purpose
Information about the drug product’s indications for use.Purpose Glycerin Hyperosmotic Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Topwin Speedy Enema Glycerin GLYCERIN GLYCERIN METHYLPARABEN SODIUM CHLORIDE SODIUM BENZOATE WATER
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.Topwin Speedy Enema NDC 73513-323-20 image description
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before using any laxative if you have a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than 1 week
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use when rectal irritation, abdominal pain, nausea, fever, or vomiting are present unless directed by a doctor.
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 If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store below 77°F (25 °C) in a cool dry place and protected from sunlight. Do not use if cap is broken.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Manufactured by Health Chemical Pharmaceutical Co, Ltd Made in Taiwan U.S. Importer: Larkin Inc. dba Asia Company 1695 Jerrold Avenue, San Francisco, CA 94124 Email: [email protected] Phone: (415)285-8888
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 using and ask a doctor if you have rectal discomfort burning sensation rectal bleeding no bowel movement within 1 hour of using this product
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 For rectal use only
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