Label: NON-HABIT FORMING STOOL SOFTENER- docusate sodium capsule, liquid filled
- NDC Code(s): 0536-3756-01, 0536-3756-10
- Packager: Rugby Laboratories Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated April 24, 2013
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- Active ingredient (in each softgel)
Docusate Sodium 100 mgClose
- for prevention of dry, hard stools
- for relief of occasional constipation
This product generally produces a bowel movement within 12 to 72 hours.Close
Do not use
- if you are currently taking mineral oil, unless directed by a doctor
- when abdominal pain, nausea, or vomiting are present
- for longer than 1 week, unless directed by a doctor
Ask a doctor before use if
if you notice a sudden change in bowel habits that persists over a period of 2 weeks.
Stop use and ask a doctor if
- you have rectal bleeding
- you fail to have a bowel movement after use
These could be signs of a serious condition.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
adults and children over 12 years of age take 1 to 3 softgels preferably at bedtime children 6-12 years of age take 1 softgel at bedtime children under 6 years ask a doctor
- Other information
- each softgel contains: sodium 6 mg
- store between 15º-30ºC (59º-86ºF)
- Inactive ingredients
edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.Close
- Questions or comments?
- Principal Display Panel
COMPARE TO ACTIVE INGREDIENT IN COLACE®*
Stool Softener Laxative
Docusate Sodium USP, 100 mg
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Rugby Laboratories is not affiliated with the owner of the trademark Colace®.
Distributed by: Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150Close
- Product Label
Rugby Stool Softener Laxative Softgel
- INGREDIENTS AND APPEARANCE
NON-HABIT FORMING STOOL SOFTENER
docusate sodium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-3756 Route of Administration ORAL DEA Schedule 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 FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color ORANGE (orange) Score no score Shape OVAL (OVAL) Size 13mm Flavor Imprint Code P51 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-3756-01 100 in 1 BOTTLE 2 NDC:0536-3756-10 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 03/29/2012 Labeler - Rugby Laboratories Inc (191427277) Registrant - P and L Development of New York Corporation (800014821)