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| Product NDC Code | 63868-282 | ||||
|---|---|---|---|---|---|
| Drug Name | Glycerin |
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| Type | Generic | ||||
| 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 | SUPPOSITORY | ||||
| RxCUI drug identifier | 421299 | ||||
| Application Number | M007 | ||||
| Labeler Name | Chain Drug Marketing Association Inc. | ||||
| 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 (in each suppository) Glycerin 1.2 g
Ask a Doctor before using any laxative if child has abdominal pain, nausea or vomiting a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than 1 week
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 dosage childrien 2 to under 6-1 suppository, or as directed by a doctor children under 2 years-ask a doctor Insert suppository well up into rectum. Suppository need not melt completely to produce laxative action.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients purified water, sodium hydroxide, stearic acid
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 this product generally produces a bowel movement in 1/4 to 1 hour
Purpose
Information about the drug product’s indications for use.Purpose Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Glycerin Glycerin WATER SODIUM HYDROXIDE STEARIC ACID GLYCERIN GLYCERIN
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.Pediatric Glycerin Suppositories, 25 count The product package shown below represents a sample of that currently in use. Additional packaging may also be available. PediatricGlycerin Suppositories, 25 count Distributed by C.D.M.A. Inc. 43157 W. Nine Mile Novi, MI 48376-0995 www.qualitychoice.com QC Pediatric25ct.jpg QCPediatric25ct
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 container tightly closed. Keep away from excessive heat.
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 consult a doctor if child has rectal bleeding no bowel movement within 1 hour of using this product These symptoms may indicate a serious condition.
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 May cause rectal discomfort or a burning sensation Ask a Doctor before using any laxative if child has abdominal pain, nausea or vomiting a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than 1 week Stop use and consult a doctor if child has rectal bleeding no bowel movement within 1 hour of using this product These symptoms may indicate a serious condition. Keep out of reach of children. If swallowed, 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