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| Product NDC Code | 0904-7332 | ||||
|---|---|---|---|---|---|
| Drug Name | Glycerin |
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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 | 421299 | ||||
| Application Number | M007 | ||||
| Labeler Name | MAJOR PHARMACEUTICALS | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Glycerin 1.2 g
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: 1 suppository or as directed by a doctor Children 2 to 6 years: tear wrapper prior to immediate use remove the secondary wrapper before inserting into the rectum as follows: - hold suppository with pointed end up - carefully separate tabs with fingernail - gently pull apart by pulling tabs down on both sides - remove suppository from wrapper - insert one suppository well up into the rectum Children under 2 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients polyethylene glycol 400, 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.Uses For relief of occasional constipation. This product usually produces a bowel movement in 1/4 to 1 hour.
Purpose
Information about the drug product’s indications for use.Purpose Hyperosmotic Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Glycerin Glycerin Suppository POLYETHYLENE GLYCOL 400 SODIUM STEARATE 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.PRINCIPAL DISPLAY PANEL MAJOR® NDC 0904-7332-17 Children's Glycerin Suppositories 1.2 g Laxative For fast, gentle relief of occasional constipation Unit Dose 25 Individually Wrapped Child Size Suppositories PDP carton
PRINCIPAL DISPLAY PANEL MAJOR® NDC 0904-7332-01 Children's Glycerin Suppositories 1.2 g Laxative For fast, gentle relief of occasional constipation DO NOT OPEN UNTIL IMMEDIATE USE Unit Dose 1 Individually Wrapped Child Size Suppository PDP pouch
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
Other information Only remove overwrap prior to immediate use Keep from excessive heat Do not use if overwrap is torn
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 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.
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 when abdominal pain, nausea 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 immediately (1-800-222-1222).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? (855) 879-4368
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 This may indicate a serious condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product rectal discomfort or burning sensation may occur
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. Do not use laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor 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. When using this product rectal discomfort or burning sensation may occur Stop use and consult a doctor if child has rectal bleeding no bowel movement within 1 hour of using this product This may indicate a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right immediately (1-800-222-1222).
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