OTC Medication Information: Stool Softener
STOOL SOFTENER- docusate sodium capsule, liquid filled
Better Living Brands, LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Active ingredient (in each liquid-filled capsule)
Docusate sodium 100 mg
Purpose
Stool softener laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Warnings
Do not use
if you are presently taking mineral oil, unless told to do so 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.
- you need to use a laxative for more than 1 week
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- take with a glass of water
- take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and over | take 1 to 3 capsules daily |
children 2 to under 12 years | take 1 capsule daily |
children under 2 years | ask a doctor |
Other information
- each capsule contains: sodium 6 mg Very Low Sodium
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- protect from excessive humidity
- see end flap for expiration date and lot number
Inactive ingredients
anhydrous citric acid, edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol
Questions or comments?
1-800-426-9391
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Quality Guaranteed
COMPARE TO
Dulcolax® Stool Softener
active ingredient*
NDC 21130-655-56
Stool Softener
DOCUSATE SODIUM 100 mg
Stool Softener Laxative
• Gentle
• Effective
• Stimulant-free
for comfortable relief
Actual Size
25 LIQUID GELS
OUR PROMISE
QUALITY & SATISFACTION
100% GUARANTEED
OR YOUR MONEY BACK.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929 www.betterlivingbrandsLLC.com
*This product is not manufactured or distributed by
Sanofi-Aventis Deutschland GMBH, distributors of
Dulcolax® Stool Softener.
50844 REV0218B65556 Product of ChinaPackaged and Quality Assured in the USA
Signature Care 44-655
STOOL SOFTENER docusate sodium capsule, liquid filled | ||||||||||||||||||||||
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Labeler — Better Living Brands, LLC (009137209) |
Establishment | |||
Name | Address | ID/FEI | Operations |
LNK International, Inc. | 038154464 | pack (21130-655) |
Establishment | |||
Name | Address | ID/FEI | Operations |
LNK International, Inc. | 832867837 | pack (21130-655) |
Establishment | |||
Name | Address | ID/FEI | Operations |
LNK International, Inc. | 868734088 | pack (21130-655) |
Establishment | |||
Name | Address | ID/FEI | Operations |
LNK International, Inc. | 967626305 | pack (21130-655) |
Revised: 06/2022 Better Living Brands, LLC
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.