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| Product NDC Code | 75981-078 | ||||
|---|---|---|---|---|---|
| Drug Name | Castor oil |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 204691 | ||||
| Application Number | M007 | ||||
| Labeler Name | Perrigo Direct, Inc | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse reaction Distributed by: Perrigo Direct, Inc, Peachtree City, GA 30269 www.PerrigoDirect.com 1-888-593-0593
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Castor oil USP 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 Adults and children over 12 years of age - 1 to a maximum of 4 Tablespoons (15 to 60 mL) in a single daily dose children 2 to under 12 years of age - 1 to a maximum of 3 teaspoons (5 to 15 mL) in a single daily dose children under 2 years of age - do not use, consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Invactive 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.Use For relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 12 hours.
Purpose
Information about the drug product’s indications for use.Purpose Stimulant laxative
Spl product data elements
Usually a list of ingredients in a drug product.Castor Oil Castor Oil CASTOR OIL CASTOR 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 NDC 75981-078-26 GoodSense® SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION Castor Oil USP Stimulant laxative 4 FL OZ (118 mL) image description
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 noticed a sudden change in bowel habits that persists over a period of 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 2 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 For a period longer than 1 week
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. In case of overdose, get medical help or contact a Poison Control Center right away.
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 failure to have a bowel movement after use. These could be signs of a serious condition.
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 keep tightly closed, away from excessive heat
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 this procduct
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