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| Product NDC Code | 70677-1090 | ||||
|---|---|---|---|---|---|
| Drug Name | Foster and thrive 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 | M007 | ||||
| Labeler Name | McKesson | ||||
| 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 ingredients (in each 118mL 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 (or as directed by a doctor) Rectal enema dosage is 118 mL in a single daily dosage (per 24 hours). Adults & children 13 years old and older 1 bottle Children 2-12 years old 1/2 bottle Children under 2 years old DO NOT USE
| Adults & children 13 years old and older | 1 bottle |
| Children 2-12 years old | 1/2 bottle |
| Children under 2 years old | 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.Use 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.Foster and Thrive 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 NDC 70677-1090-1 COMPARE TO FLEET ® MINERAL OIL ENEMA ACTIVE INGREDIENTS* Foster & Thrive™ READY TO USE Enema MINERAL OIL Lubricated Tip Sodium Free Not Made With Natural Rubber Latex For Relief of: Occassional Constipation NOT ACTUAL SIZE 1 BOTTLE 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: McKesson Corp., via Strategic Sourcing Services LLC. Memphis, TN 38141
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 1 week have abdominal pain, nausea, or vomiting have a sudden change in bowel habits that persist over a period of 2 weeks
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: 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? 833-358-6431
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 fail to have a bowel movement after use
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 15 to 30°C (59 to 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. Ask a doctor before use if you have already used a laxative for more than 1 week have abdominal pain, nausea, or vomiting have a sudden change in bowel habits that persist over a period of 2 weeks Stop use and ask a doctor if you have rectal bleeding you fail to have a bowel movement after use If pregnant or breast-feeding, 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: 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