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| Product NDC Code | 30142-005 | ||||
|---|---|---|---|---|---|
| Drug Name | Saline 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 | Kroger Company | ||||
| Packages |
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Overdosage of Saline Laxative
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Dosage warning: Using more than one enema in 24 hours can be harmful.
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 Do not use more unless directed by a doctor. See Warnings. adults & children 12 years and over one bottle once daily children 2 to under 12 years 1/2 bottle once daily Discard unused portion children under 2 years 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 with tip pointing toward navel. • squeeze bottle until recommended dose is expelled (it is not necessary to empty unit completely. Bottle contains more liquid than needed for effective use. A small amount of liquid will remain in bottle after squeezing). • remove tip from 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. • maintain 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
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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
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.Saline Laxative sodium phosphate SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM PHOSPHATE ION SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM PHOSPHATE ION BENZALKONIUM CHLORIDE EDETATE DISODIUM WATER
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 - 2 Bottle Carton COMPARE TO the active ingredients of FLEET ® ENEMA SALINE *See side panel NDC 30142-005-35 TWIN PACK Kroger ® OUR PHARMACIST RECOMMENDED READY-TO-USE Enema SALINE LAXATIVE Soft, Flexible Tip For Relief of Occasional Constipation - Lubricated Tip for Comfort Application - Pre-Mixed - Not Made with Natural Rubber Latex TAMPER EVIDENT SAFETY SEALED BOTTLES FAST RELIEF 2 BOTTLES 4.5 FL OZ (133 ml) EACH TOTAL 9 FL OZ (266 mL) Principal Display Panel - 2 Bottle Carton
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 • a sodium-restricted diet • abdominal pain, nausea or vomiting • kidney disease, heart problems, or are dehydrated • noticed a sudden change in bowel habits that lasts over 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.
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? 1-800-633-5463
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 after use of a laxative These may be signs of 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
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 at room temperature 20-25 deg C (68-77 deg F) • this product generally produces bowel movement in 1 to 5 minutes
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 Dosage warning: Using more than one enema in 24 hours can be harmful. Ask a doctor before use if you have • a sodium-restricted diet • abdominal pain, nausea or vomiting • kidney disease, heart problems, or are dehydrated • noticed a sudden change in bowel habits that lasts over 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 Stop use and ask a doctor if • you have rectal bleeding • you have no bowel movement after use of a laxative These may be signs of 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