Active Ingredient (In Each Tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg
Stool Softener With Laxative Tablet, Film Coated
FDA Label NDC 71335-2522
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Stool Softener With Laxative (NDC 71335-2522). 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 active ingredient (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool softener
Stimulant laxative
Uses
- relieves occasional constipation (irregularity)
- this product generally produces bowel movement in 6 to 12 hours
Warnings
Do not use
- laxative products for longer than 1 week unless directed by a doctor
- if you are presently taking mineral oil, unless directed by a doctor
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
Ask a doctor before use if you have
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.
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 over | take 2-4 tablets daily |
| children under 12 years of age | ask a doctor |
Other Information
- each tablet contains: calcium 20 mg, sodium 3 mg
- store at controlled room temperature
- Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
- product of India
Inactive Ingredients
cellulose, croscarmellose sodium, dicalcium phosphate, FD&C blue #2 lake, FD&C red #40 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.
How Supplied
Stool softener with stimulant laxative each tablet contains docusate sodium 50 mg sennosides 8.6 mg. Red colored, round shaped and the imprint code in PSD21.
NDC: 71335-2522-1: 30 Tablets in a BOTTLE
NDC: 71335-2522-2: 120 Tablets in a BOTTLE
NDC: 71335-2522-3: 60 Tablets in a BOTTLE
NDC: 71335-2522-4: 90 Tablets in a BOTTLE
NDC: 71335-2522-5: 100 Tablets in a BOTTLE
NDC: 71335-2522-6: 28 Tablets in a BOTTLE
NDC: 71335-2522-7: 56 Tablets in a BOTTLE
NDC: 71335-2522-8: 14 Tablets in a BOTTLE
NDC: 71335-2522-9: 20 Tablets in a BOTTLE
Store at controlled room temperature.
Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
Package Label.Principal Display Panel
Docusate/ Sennosides 50/8.6 mg Tablet
Label (Lbl713352522)
* Please review the disclaimer below.
