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- NDC Code(s): 0869-0078-26
- Packager: Vi-Jon, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 8, 2022
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
Distributed by: Vi-Jon, INC.,
One Swan Drive, Smyrna, TN 37167
- Active ingredient
Castor Oil USP 100%
- Purpose
Stimulant laxative
- Use
For relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 12 hours.
- warnings
- Do not use
for a period longer than 1 week
- 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 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.
- 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.
- If pregnant or breast feeding
ask a health professional before use.
- Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
- 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
- other information
keep tightly closed, away from excessive heat
- Inactive Ingredient
None
- principal display panel
NDC 0869-0078-26
Swan
Caster Oil
U.S.P. STIMULANT LAXATIVE
For the Relief of Occasional Constipation
DO NOT USE IF PRINTED NECKBAND IS BROKWN OR MISSING.
4FL OZ (118mL)
See AlsoCastor Oil oral solution - principal display panel
Sealed with printed neckband for your protection
mountain falls
castor oil U.S.P.
stimulant laxative
4 FL OZ (118 mL)
- INGREDIENTS AND APPEARANCE
CASTOR OIL
castor oil liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0869-0078 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASTOR OIL (UNII: D5340Y2I9G) (CASTOR OIL - UNII:D5340Y2I9G) CASTOR OIL 1g in1mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0869-0078-26 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1989 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 07/15/1989 Labeler -Vi-Jon, LLC(790752542)
Registrant -Vi-Jon, LLC (790752542)
Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(0869-0078) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(0869-0078)
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Safety
Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk
Related Resources
Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary
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CASTOR OIL liquid
Number of versions: 8
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CASTOR OIL liquid
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NDC Codes
CASTOR OIL liquid
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
NDC | |
---|---|
1 | 0869-0078-26 |
Given the complexity and specificity of the article you provided, let's delve into each of the concepts and terms mentioned to give a comprehensive understanding:
-
Label RSS: RSS (Really Simple Syndication) is a technology used to syndicate content on the web. In the context of drug labels, a Label RSS would provide updates or notifications about changes, additions, or modifications to the drug label information. Users can subscribe to this feed to stay updated.
-
View Package Photos: This feature would allow users to view photos of the drug's packaging. It aids in identification and ensures that consumers and healthcare providers can verify they have the correct product.
-
Drug Label Info: This refers to detailed information about a drug, including its active ingredients, uses, warnings, directions for use, and other relevant information. It serves as a comprehensive guide for both healthcare providers and consumers.
-
Safety & Report Adverse Events: This emphasizes the importance of monitoring a drug's safety profile. Users can report any adverse reactions or events they experience or observe, allowing regulatory bodies like the FDA to monitor and evaluate the drug's safety.
-
FDA Safety Recalls: If a drug poses a risk to public health, the FDA may issue a recall. This involves removing the drug from the market or correcting the issue to ensure safety.
-
Presence in Breast Milk: This indicates whether the drug's components can pass into breast milk, potentially affecting nursing infants. Such information is crucial for lactating mothers and healthcare providers to make informed decisions about medication use.
-
Medline Plus, Clinical Trials, PubMed: These are reputable resources for accessing medical and scientific literature.
- Medline Plus provides consumer-friendly health information.
- Clinical Trials offers information about ongoing or completed medical research studies.
- PubMed is a database of biomedical literature from various sources, including research articles, reviews, and more.
-
Adverse Effects: These are unwanted or harmful effects that can result from drug use. They can range from mild to severe and may necessitate discontinuation or modification of treatment.
-
Therapeutic Use: Refers to the intended medical uses of a drug. It outlines the conditions or diseases the drug is designed to treat or manage.
-
Pharmacology: This is the study of how drugs interact with living organisms to produce a change in function. It encompasses the drug's effects, mechanisms of action, and its therapeutic and toxic effects.
-
Biochemical Data Summary: Provides a detailed overview of the drug's biochemical properties, including its molecular structure, interactions, metabolism, and other relevant biochemical data.
-
RxNorm & NDC Code:
- RxNorm is a standardized nomenclature for clinical drugs. It provides unique identifiers for medications to facilitate interoperability between electronic systems.
- NDC (National Drug Code) is a unique identifier for drugs in the United States. It consists of three segments: the labeler code, the product code, and the package code.
In summary, the provided article delves deep into the specifics of Castor Oil as an over-the-counter stimulant laxative. It offers comprehensive details about its composition, usage directions, warnings, safety considerations, and regulatory information. Understanding such details is crucial for safe and effective use of the product.