Label: STOOL SOFTENER REGULAR STRENGTH- docusate sodium capsule, liquid filled
- NDC Code(s): 68196-998-60
- Packager: Sam's West, Inc
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated July 31, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
- Directions
- Other information
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Inactive ingredients
ammonium hydroxide, anhydrous citric acid, D&C red #33, ethyl alcohol, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mineral oil, n-butyl alcohol, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide
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Principal Display Panel
Compare to COLACE® ACTIVE INGREDIENT†
Stool Softener
DOCUSATE SODIUM 100 mg
Stool Softener Laxative
GENTLE & DEPENDABLE
STIMULANT-FREE
SEE DIRECTIONS FOR SERVING SIZE
SOFTGELS
†This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., distributor of Colace® Regular Strength Stool Softener.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY
SAM'S WEST, INC.
BENTONVILLE, AR 72716
- Product Label
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INGREDIENTS AND APPEARANCE
STOOL SOFTENER REGULAR STRENGTH
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68196-998 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ALCOHOL (UNII: 3K9958V90M) ISOPROPYL ALCOHOL (UNII: ND2M416302) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MINERAL OIL (UNII: T5L8T28FGP) AMMONIA (UNII: 5138Q19F1X) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) Product Characteristics Color red, white Score no score Shape OVAL Size 12mm Flavor Imprint Code PC18 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68196-998-60 600 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007 07/15/2022 Labeler - Sam's West, Inc (051957769)