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| Product NDC Code | 57348-897 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Super colon cleanse |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||||
| Dosage Form | CAPSULE | ||||||||||
| RxCUI drug identifier | 2118713 | ||||||||||
| Application Number | 505G(a)(3) | ||||||||||
| Labeler Name | Health Plus Inc. | ||||||||||
| 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 (per capsulle) Sennosides 8.3mg Purpose Stimulant 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 this product with a full glass (8oz) of water or other liquid. Taking this product without enough liquid may cause choking. (See choking warning.) adults and children 12 years of age and older: 2 capsules 2 times daily children 6 to under 12 years of age: 1 capsule once or twice daily children under 6 years of age: consult a doctor
| adults and children 12 years of age and older: | 2 capsules 2 times daily |
| children 6 to under 12 years of age: | 1 capsule once or twice daily |
| children under 6 years of age: | consult a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients fennel seed powder, gelatin, lactobacillus acidophilus powder, papaya leaf powder, psyllium husk powder, rose hips fruit powder
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 relieves occasional constipation (irregularity) generally produces a 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.Super Colon Cleanse SENNOSIDES GELATIN, UNSPECIFIED SENNOSIDES SENNOSIDES
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.Super Colon Cleanse, 60ct (57348-897-60) label60
Super Colon Cleanse, 100ct(57348-897-10) Label100
Super Colon Cleanse, 120ct(57348-897-12) label 120
Super Colon Cleanse, 240ct(57348-897-24) label240
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
Other information • store below 86°F (30°C)
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 • vomiting • noticed a sudden change in bowel habits that continues for a period of 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 laxative products 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? 1-800-822-6225
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 bowel movement after use of a laxative. These may indicale a serious condition
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, • ask a health professional before use
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 Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain. vomiting or difficulty in swallowing or breathing after taking this product seek immediate medical attention Do not use laxative products longer than 1 week unless directed by a doctor Ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that continues for a period of 2 weeks. Stop use and ask a doctor if • you have rectal bleeding • you fail to have bowel movement after use of a laxative. These may indicale 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