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| Product NDC Code | 69729-151 | ||||
|---|---|---|---|---|---|
| Drug Name | Colon detox |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 998740 | ||||
| Application Number | M007 | ||||
| Labeler Name | OPMX LLC | ||||
| 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 Purpose Active ingredients (in each tablet) Purpose Docusate sodium 50 mg Stool softner Sennosides 8.6 mg Laxative
| Docusate sodium 50 mg | Stool softner |
| Sennosides 8.6 mg | Laxative |
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 take preferably at bedtime or as directed by a doctor age starting dose maximum dose adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor
| adults and children 12 years of age and older | 2 tablets once a day | 4 tablets twice a day |
| children 6 to under 12 years | 1 tablet once a day | 2 tablets twice a day |
| children 2 to under 6 years | 1/2 tablet once a day | 1 tablet twice a day |
| children under 2 years | ask a doctor | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients croscarmellose sodium, colloidal silicon dioxide, dicalcium phosphate, D&C Yellow #10, FD&C Yellow #6, hypromellose, microcrystalline cellulose, magnesium stearate, maltodextrin, polyethylene glycol, stearic acid, titanium dioxide.
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 (irregularity). This product generally produces bowel movement in 6 to 12 hours.
Purpose
Information about the drug product’s indications for use.Purpose Active ingredients (in each tablet) Purpose Docusate sodium 50 mg Stool softner Sennosides 8.6 mg Laxative
| Docusate sodium 50 mg | Stool softner |
| Sennosides 8.6 mg | Laxative |
Spl product data elements
Usually a list of ingredients in a drug product.Colon Detox Docusate sodium and Sennosides DOCUSATE SODIUM DOCUSATE CELLULOSE, MICROCRYSTALLINE MALTODEXTRIN CROSCARMELLOSE SODIUM POLYETHYLENE GLYCOL, UNSPECIFIED STEARIC ACID SILICON DIOXIDE D&C YELLOW NO. 10 TITANIUM DIOXIDE SENNOSIDES SENNOSIDES ANHYDROUS DIBASIC CALCIUM PHOSPHATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE FD&C YELLOW NO. 6 P
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.Colon Detox Colon Detox Colon Cleanser Helps Lose Belly Fat Stool Softener 60 Tablets CD
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
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 stomach pain nausea vomitting noticed a sudden change in bowel habits that lasts over 2 weeks
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 if you are presently taking mineral oil, unless directed by a doctor. laxative products should not be used for a period longer than 1 week unless directed by a 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 In case of overdose, get medical help or contact a Poison Control Center right away.
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? Call toll free 1-844-832-1138 Monday through Friday 9AM-5PM EST or https://www.opmx.us
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 of a laxative. These may indicate a serious condition.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)If 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 each tablet contains: calcium 21 mg each tablet contains: sodium 3 mg VERY LOW SODIUM store at 25°C (77°F); excursions permitted between 15°- 30°C (59°- 86°F). read all product information before using TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN 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 Do not use if you are presently taking mineral oil, unless directed by a doctor. laxative products should not be used for a period longer than 1 week unless directed by a doctor. Ask a doctor before use if you have stomach pain nausea vomitting noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use of a laxative. These may indicate 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.
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