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| Product NDC Code | 53329-013 | ||||
|---|---|---|---|---|---|
| Drug Name | Pure and gentle |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | RECTAL | ||||
| Dosage Form | ENEMA | ||||
| RxCUI drug identifier | 205121 | ||||
| Application Number | part334 | ||||
| Labeler Name | Medline Industries, LP | ||||
| 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 120 mL delivered dose) Mineral oil 100% w/v
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 (or as directed by a doctor) Rectal enema dosage is 120 mL in a single daily dosage (per 24 hours) adults & children 13 years and over 1 bottle children under 13 years of age DO NOT USE Caution: Remove green protective shield before inserting: hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove Positioning: Left-side position: Lie on left side with knee bent and arms at rest. Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably. Administering enema: With steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus. Do not force the enema tip into rectum as this can cause injury. Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more liquid than needed. Remove enema tip from rectum. This product generally produces a bowel movement in 2 to 15 minutes. Do not retain enema solution in body for longer than 15 minutes. Remove protective shield illustration Left Side position illustration Knee-chest position illustration
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient none
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 bowel movement in 2 to 15 minutes
Purpose
Information about the drug product’s indications for use.Purpose Lubricant laxative
Spl product data elements
Usually a list of ingredients in a drug product.Pure and Gentle mineral oil MINERAL OIL MINERAL OIL
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.Package Label 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.Manufacturing Information Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 Made in USA www.medline.com 1-800-MEDLINE (633-5463) REF: CUR095010 V1 RD22NPX
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 you have already used a laxative for more than 3 days have abdominal pain, nausea or vomiting have a sudden change in bowel habits that persists over a period of 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 on children under 13 years of age on pregnant women on persons with difficulty swallowing on bedridden patients if you are presently taking a stool softener laxative or take with meals
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. (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 or comments? 1-866-323-0107 M-F 8 am to 5 pm
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 you have rectal bleeding you have no bowel movement within 30 minutes of enema use
Pregnancy or breast feeding
Pregnancy or Breast feedingAs with any drug, if you are nursing a baby, seek the advice of a health professional before using this product.
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at room temperature 15-30°C (59-86°F) Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.
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 Caution: to be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician. Do not use on children under 13 years of age on pregnant women on persons with difficulty swallowing on bedridden patients if you are presently taking a stool softener laxative or take with meals Ask a doctor before use if you have already used a laxative for more than 3 days have abdominal pain, nausea or vomiting have a sudden change in bowel habits that persists over a period of 2 weeks Stop use and ask a doctor if you have rectal bleeding you have no bowel movement within 30 minutes of enema use As with any drug, if you are nursing a baby, seek the advice of a health professional before using this product. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (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