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| Product NDC Code | 57237-326 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Glycerin children |
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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 | M007.54 | ||||||
| Labeler Name | Rising Pharma Holdings, 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 USP, 1.2 grams
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 : 1 suppository once daily children under 2 years : ask a doctor insert 1 suppository well up into the rectum and retain for 15 minutes it need not melt to produce laxative action
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.Uses for relief of occasional constipation this product usually produces 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 Children Glycerin WATER SODIUM STEARATE GLYCERIN GLYCERIN clear
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.NDC 57237-326-52 (5 blisters of 5 suppositories) Children's Glycerin Suppositories 1.2 g LAXATIVE For fast, gentle relief of occasional constipation For ages 2 to 5 years NDC 57237-326-51 (5 suppositories in 1 blister pack) Front Foil Back Foil Gly-child-supp-01 Gly-child-supp-02 Gly-child-supp-03 Gly-child-supp-04
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
TAMPER EVIDENT: DO NOT USE IF SEALED WRAPPER AROUND SUPPOSITORIES IS BROKEN OR MISSING
Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Made in India CODE NO.: MH/DRUGS/25-KD/724 Issued: 08/2023
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 the child has stomach pain, nausea or vomiting a sudden change in bowel habits lasting more than 2 weeks
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 for longer than one 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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? Call 1-844-474-7464
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 child has rectal bleeding no bowel movement after using this product These 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 your child may have rectal discomfort or a burning sensation
Storage and handling
Information about safe storage and handling of the drug product.Other information keep away from excessive heat.
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 for longer than one week unless directed by a doctor Ask a doctor before use if the child has stomach pain, nausea or vomiting a sudden change in bowel habits lasting more than 2 weeks When using this product your child may have rectal discomfort or a burning sensation Stop use and ask a doctor if child has rectal bleeding no bowel movement after using this product These 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