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| Product NDC Code | 70000-0109 | ||||
|---|---|---|---|---|---|
| Drug Name | Leader ready to use mineral oil laxative |
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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 | Cardinal Health | ||||
| 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) Mineral oil 100%
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 dose (per 24 hours). adults & children 12 years and over 1 bottle once daily children 2 to under 12 years 1/2 bottle once daily discard unused portion children under 2 years DO NOT USE
| adults & children 12 years and over | 1 bottle once daily |
| children 2 to under 12 years | 1/2 bottle once daily discard unused portion |
| children under 2 years | DO NOT USE |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients 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 for relief of fecal impaction for removal of residue after barium administration
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.Leader Ready to Use Mineral Oil Laxative 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.PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton LEADER ™ NDC 70000-0109-1 Ready-To-Use Enema Mineral Oil Lubricant Laxative Sodium Free For Relief Of: Occasional Constipation Comfortable, Lubricated Tip Works in Minutes Not Made With Natural Rubber Latex COMPARE TO FLEET ® MINERAL OIL ENEMA active ingredient* 1 BOTTLE 100% Money Back Guarantee 4 .5 FL OZ (133 mL) PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
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
DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017
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 abdominal pain, nausea, or vomiting if you have a sudden change in bowel habits that persists over a period of 2 weeks if you have already used a laxative for more than 1 week if constipation continues after one week of use, contact your 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 to prevent accidental ingestion. 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
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 or no bowel movement within 15 minutes of using this product you need to use a laxative for more than one week These symptoms may indicate a serious condition.
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 store at 15°-30°C (59°-86°F) this product generally produces a bowel movement in 2 to 15 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 Ask a doctor before use if you have abdominal pain, nausea, or vomiting if you have a sudden change in bowel habits that persists over a period of 2 weeks if you have already used a laxative for more than 1 week if constipation continues after one week of use, contact your doctor Stop use and ask a doctor if you have rectal bleeding or no bowel movement within 15 minutes of using this product you need to use a laxative for more than one week These symptoms may indicate a serious condition. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children to prevent accidental ingestion. 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