FDA Label for Stool Softener With Laxative
View Indications, Usage & Precautions
Stool Softener With Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Bryant Ranch Prepack. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg
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
* Please review the disclaimer below.
