Stool Softener Plus Stimulant Laxative
FDA Label NDC 41250-739
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc. for the product Stool Softener Plus Stimulant Laxative (NDC 41250-739). 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 drug facts, active ingredients (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Tablet)
Docusate sodium 50 mg
Sennosides 8.6 mg
Purpose
Stool softener
Stimulant Laxative
Uses
■ relieves occasional constipation (irregularity)
■ generally produces bowel movement in 6-12 hours
Warnings
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
Ask A Doctor Before Use If You Have
■ stomach pain ■ nausea ■ vomiting
■ noticed a sudden change in bowel habits that lasts over 2
weeks
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
Drug Facts (continued)
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. 1-800-222-1222
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 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 | ask a doctor |
Other Information
■ each tablet contains: calcium 20 mg, sodium 6 mg
■ store at 25°C (77°F); excursions permitted between
15°-30°C (59°-86°F)
Inactive Ingredients
Colloidal silicon dioxide, croscarmellose sodium, dicalcium
phosphate, FD&C Red #40, hypermellose, magnesium
stearate, maltodextrin, microcrystalline cellulose, polyethylene
glycol-400, purified water, sodium benzoate, stearic acid,
titanium dioxide
Questions Or Comments?
1-888-333-9792
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COMPARE TO THE ACTIVE
INGREDIENTS OF PERI-COLACE®†
Stool Softener
with Stimulant Laxative
Docusate Sodium 50 mg
Sennosides 8.6 mg
Relieves
Constipation
ACTUAL SIZE
100 TABLETS
* Please review the disclaimer below.
