Otc - Active Ingredient
Active ingredients (in each tablet)
Docusate sodium 50 mg
Sennosides 8.6 mg
Natural Vegetable Laxative And Stool Softener Tablet
FDA Label NDC 21130-219
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands Llc. for the product Natural Vegetable Laxative And Stool Softener (NDC 21130-219). 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, indications & usage, warnings, otc - do not use, otc - ask doctor/pharmacist, 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
Laxative
Indications & Usage
Uses
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 6-12 hours
Warnings
Warnings
Otc - Do Not Use
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
Otc - Ask Doctor/Pharmacist
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
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 may indicate 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Dosage & Administration
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 |
Other Safety Information
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)
Inactive Ingredient
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
Otc - Questions
Questions or comments? Call 1-877-290-4008
Package Label.Principal Display Panel
192r_albertsons_lbl_30ct (192r Albertsons Lbl 30ct)
192r_albertsons_ifc_30ct (192r Albertsons Ifc 30ct)
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