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| Product NDC Code | 11822-1572 | ||||
|---|---|---|---|---|---|
| Drug Name | Laxative |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 1791612 | ||||
| Application Number | M007 | ||||
| Labeler Name | RITE AID CORPORATION | ||||
| 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 (in each Softgel) 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 Dosage Maximum Dosage adults & children 12 years of age & over 2 tablets once a day 4 tablets twice a day children 6 to under 12 years of age 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 & children 12 years of age & over | 2 tablets once a day | 4 tablets twice a day |
| children 6 to under 12 years of age | 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 Light liquid paraffin, Soya lecithin, Beeswax, Colloidal silicon dioxide (aerosol), Sodium Carboxymethyl Cellulose, titanium dioxide, Gelatin, Glycerin, Sorbitol sorbitan, Povidone, FD&C Yellow-6, FD&C Red-33, spl, Purified water
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 bowel movement in 6–12 hours
Purpose
Information about the drug product’s indications for use.Purpose Stool softener Laxative
Spl product data elements
Usually a list of ingredients in a drug product.LAXATIVE Docusate sodium and Sennosides PARAFFIN LECITHIN, SOYBEAN SYNTHETIC BEESWAX SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM TITANIUM DIOXIDE GELATIN GLYCERIN NONCRYSTALLIZING SORBITOL SOLUTION POVIDONE K30 FD&C YELLOW NO. 6 D&C RED NO. 33 FD&C RED NO. 40 WATER DOCUSATE SODIUM DOCUSATE SENNOSIDES SENNOSIDES 584
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.Label Laxative label Carton Laxative carton
Carton Laxative carton
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
Distributed by: RITE AID 30 Hunter Lane, Camp Hill, PA 17011 www.riteaid.com Made in India
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 over a period of 2 weeks
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 or pharmacist before use if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.
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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
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? 1-888-333-9792
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 could be signs of a serious condition • you need to use a stool softener laxative for more than 1 week
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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 2 mg and sodium 6 mg • store at 25°C (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 • if you are now taking mineral oil, unless directed by a doctor • laxative products for 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 over a period of 2 weeks Ask a doctor or pharmacist before use if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition. 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 • you need to use a stool softener laxative for more than 1 week 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. (1-800-222-1222)
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