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| Product NDC Code | 76162-005 | ||||
|---|---|---|---|---|---|
| Drug Name | Senna lax |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 312935 | ||||
| Application Number | M007 | ||||
| Labeler Name | TopCo Associates, 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 ingredient(s) Sennosides 8.6mg
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 Dosage 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 | 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 |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, silicon 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.Use(s) relieves occasional constipation (irregularity) generally produces a bowel movement in 6-12 hours
Purpose
Information about the drug product’s indications for use.Purpose Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Senna Lax Sennosides 8.6mg SENNOSIDES SENNOSIDES CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE
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 Senna Lax Senna Lax
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.Other information each tablet contains: calcium 50mg do not use if safety seal under cap is broken or missing
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 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 laxative products for longer than one 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 accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.
Pregnancy or breast feeding
Pregnancy or Breast feedingPregnancy/Breastfeeding ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Storage store at 20°C-25°C (68°F-77°F); excursions permitted between 15°-30°C (59°-86°F)
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 laxative products for longer than one week unless directed by a doctor Ask a doctor before use if stomach pain nausea vomiting noticed a sudden change in bowel habits that continues over a period of 2 weeks Stop Use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. Pregnancy/Breastfeeding ask a health professional before use Keep out of reach of children In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.
Stop Use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
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