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| Product NDC Code | 21130-219 | ||||
|---|---|---|---|---|---|
| Drug Name | Natural vegetable laxative and stool softener |
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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 | BETTER LIVING BRANDS 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 (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg
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 dosage adults and children 12 years of age and over 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 ½ 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 over | 4 tablets twice a day | |
| 1 tablet once a day | 2 tablets twice a day | |
| 1 tablet twice a day | ||
| children under 2 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, 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 relieves occasional constipation (irregularity) generally produces a bowel movement in 6-12 hours
Purpose
Information about the drug product’s indications for use.Purposes Stool softener Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Natural Vegetable Laxative and Stool Softener Docusate sodium and Sennosides CARNAUBA WAX SILICON DIOXIDE D&C YELLOW NO. 10 ALUMINUM LAKE FD&C YELLOW NO. 6 MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED DOCUSATE SODIUM DOCUSATE SENNOSIDES SENNOSIDES DIBASIC CALCIUM PHOSPHATE DIHYDRATE MICROCRYSTALLINE CELLULOSE SODIUM BENZOATE STEARIC ACID TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED CROSCARMELLOSE SODIUM TCL081
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.192R_Albertsons_Lbl_30ct 192R_Albertsons_IFC_30ct
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 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 before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that continues over 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 if you are now taking mineral oil, unless directed by a doctor laxative products for 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM) store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
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 1-877-290-4008
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 fail to have a bowel movement after use of a laxative. These may indicate 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
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