Otc - Active Ingredient
Active ingredients (in each tablet)
Docusate sodium 50 mg
Sennosides 8.6 mg
Stool Softener And Stimulant Laxative Tablet
FDA Label NDC 37808-549
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H-e-b for the product Stool Softener And Stimulant Laxative (NDC 37808-549). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purposes
Stool Softener
Stimulant laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6 to 12 hours
Warnings
Warnings
Otc - Do Not Use
- laxative products for longer than 1 week unless told to do so by a doctor
- if you are presently taking mineral oil, unless told to do so by a doctor
Otc - Ask Doctor
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses
adults and children 12 years and older take 2-4 tablets daily
children 6 to under 12 years of age take 1-2 tablets daily
children 2 to under 6 years of age take up to 1 tablet daily
children under 2 years ask a doctor
Other Information
- each tablet contains: calcium 20 mg, sodium 6 mg (VERY LOW SODIUM)
- Store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredient
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide
Otc - Questions
Questions or comments call 1-877-290-4008
Package Label.Principal Display Panel
Heb209r-240ct-peelback (Heb209r 240ct Peelback)
Heb209r-240ct (Heb209r 240ct)
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