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| Product NDC Code | 58980-409 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Stratuscare glycerin laxative pediatric |
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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 | SUPPOSITORY | ||||||
| RxCUI drug identifier | 252062 | ||||||
| Application Number | part334 | ||||||
| Labeler Name | Stratus Pharmaceuticals | ||||||
| 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 (per suppository) Glycerin, USP 1g
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 Children 2 to under 6 years of age: Carefully insert one suppository well into child's rectum It need not melt completely to produce laxative action Generally produces bowel movement in 15 minutes to 1 hour Do not exceed one suppository daily unless directed by a doctor Children under 2 years old: Consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients purified water, sodium 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.Use For relief of occasional constipation (irregularity) generally produces bowel movement in ¼ 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.Stratuscare Glycerin Laxative Pediatric Glycerin Glycerin Glycerin Water SODIUM STEARATE
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 - 25 Suppository Jar Label NDC 58980-409-25 STRATUSCARE INFANTS & CHILDREN pediatrics Glycerin Suppositories Laxative Distributed by: STRATUS PHARMACEUTICALS INC 25 SUPPOSITORIES DO NOT USE IF INNER SEAL IS BROKEN OR MISSING. Principal Display Panel - 25 Suppository Jar Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Distributed by: Stratus Pharmaceuticals Inc 12379 SW 130th Street Miami, Florida 33186
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 use if your child has: abdominal pain, nausea or vomiting a sudden change in bowel habits lasting more than 2 weeks. Stop use and ask a doctor: if your child has rectal bleeding or fails to have a bowel movement after using a laxative. This may indicate a serious condition.
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 laxative products for longer than 1 week 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 the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-442-7882
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 your child has rectal bleeding or fails to have a bowel movement after using a laxative. This may indicate a serious condition.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store glycerin suppositories at room temperature, between 15°C and 30°C (between 59°F and 86°F)
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 burning sensation. Ask a doctor before use if your child has: abdominal pain, nausea or vomiting a sudden change in bowel habits lasting more than 2 weeks. Stop use and ask a doctor: if your child has rectal bleeding or fails to have a bowel movement after using a laxative. This may indicate a serious condition. Do not use laxative products for longer than 1 week unless directed by a doctor Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212).
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