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| Product NDC Code | 53329-014 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Pure and gentle laxative |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | RECTAL | ||||||
| Dosage Form | ENEMA | ||||||
| RxCUI drug identifier | 283100 | ||||||
| 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 118 mL delivered dose) Dibasic sodium phosphate 7 g Monobasic sodium phosphate 19 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 (or as directed by a doctor) Single daily dosage (per 24 hours) Do not use if taking another sodium phosphate product. Do not use more unless directed by a doctor. See Warnings. adults & children 12 years and over 1 bottle once daily children 2 to under 12 years Use Pediatric Enema children under 2 years DO NOT USE CAUTION: Remove protective shield from enema tip before inserting. Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove. Positions for using this enema: 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 with left arm folded 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. Doing so helps relax muscles around anus. Do not force enema tip into rectum. Stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care. Squeeze bottle until nearly all liquid is gone. It is not necessary to empty unit completely, as it containsmore liquid than needed. Remove tip from rectum and stay in position until urge to evacuate is strong (usually 1 to 5 minutes). If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur. Remove protective shield illustration Left Side position illustration Knee-chest position illustration Directions (or as directed by a doctor) Single daily dosage (per 24 hours) Do not use if taking another sodium phosphate product. Do not use more unless directed by a doctor. See Warnings Adults and children 12 years old and older 1 bottle once daily Children 2 to under 12 years old Use Pediatric Enema Children under 2 years DO NOT USE CAUTION: Remove protective shield from enema tip before inserting. Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove. Positions for using this enema: Left-side position: Lie on left side with knees bent and arms resting comfortably. Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded 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. Doing so helps relax muscles around anus. Do not force enema tip into rectum. Stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care. Squeeze bottle until nearly all liquid is gone. It is not necessary to empty bottle completely, as it contains more liquid than needed. Remove tip from rectum and stay in position until urge to evacuate is strong (usually 1 to 5 minutes). If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur. image 1 image 2 image 3
| Adults and children 12 years old and older | 1 bottle once daily |
| Children 2 to under 12 years old | Use Pediatric Enema |
| Children under 2 years | DO NOT USE |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, disodium EDTA, purified water
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 relieves occasional constipation this product generally produces bowel movement in 1 to 5 minutes
Purpose
Information about the drug product’s indications for use.Purpose Saline laxative
Spl product data elements
Usually a list of ingredients in a drug product.Pure and Gentle Laxative sodium phosphate BENZALKONIUM CHLORIDE EDETATE DISODIUM WATER SODIUM PHOSPHATE, DIBASIC PHOSPHATE ION SODIUM PHOSPHATE, MONOBASIC PHOSPHATE ION
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 PDP Label V1 RD22NPX
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Directions (or as directed by a doctor) Single daily dosage (per 24 hours) Do not use if taking another sodium phosphate product. Do not use more unless directed by a doctor. See Warnings Adults and children 12 years old and older 1 bottle once daily Children 2 to under 12 years old Use Pediatric Enema Children under 2 years DO NOT USE CAUTION: Remove protective shield from enema tip before inserting. Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove. Positions for using this enema: Left-side position: Lie on left side with knees bent and arms resting comfortably. Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded 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. Doing so helps relax muscles around anus. Do not force enema tip into rectum. Stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care. Squeeze bottle until nearly all liquid is gone. It is not necessary to empty bottle completely, as it contains more liquid than needed. Remove tip from rectum and stay in position until urge to evacuate is strong (usually 1 to 5 minutes). If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur. image 1 image 2 image 3
| Adults and children 12 years old and older | 1 bottle once daily |
| Children 2 to under 12 years old | Use Pediatric Enema |
| Children under 2 years | DO NOT USE |
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 USA Made in USA www.medline.com 1-800-MEDLINE (633-5463) REF: CUR095005 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 kidney disease, have heart problems, or are dehydrated are 55 years of age or older are on a sodium-restricted diet have abdominal pain, nausea or vomiting have a sudden change in bowel habits lasting more than 2 weeks
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
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 2 years of age
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? 866-323-0107
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 you have symtoms of dehydration (thirstiness, dissiness, vomiting, urinating less oftan than normal) These symptoms 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 do not use more than directed. Serious side effects may occur from excess dosage do not use for more than 3 days, without asking a doctor
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other Information each 118 mL contains sodium 4.3 g store at15-30°C (59-86°F) additional liquids by mouth are recommended while using this product 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 Dosage warning: Using more than one enema in 24 hours can be harmful. For rectal use only. Do not use on children under 2 years of age Ask a doctor before use if you have already used a laxative for more than 3 days have kidney disease, have heart problems, or are dehydrated are 55 years of age or older are on a sodium-restricted diet have abdominal pain, nausea or vomiting have a sudden change in bowel habits lasting more than 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. When using this product do not use more than directed. Serious side effects may occur from excess dosage do not use for more than 3 days, without asking a doctor Stop use and ask a doctor if you have rectal bleeding you have no bowel movement within 30 minutes of enema use you have symtoms of dehydration (thirstiness, dissiness, vomiting, urinating less oftan than normal) These symptoms may indicate a serious condition. If pregnant or breastfeeding, ask a health professional before use. 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