Label: DOCUSATE SODIUM capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 21695-590-00, 21695-590-20, 21695-590-30, 21695-590-90 - Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 57896-401
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 15, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep Out of Reach of Children
- Uses
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Warnings
Do not use for more than one week unless directed by a doctor.
Ask a doctor before use if you have abdominal pain, nausea, or vomiting; have noticed a sudden change in bowel habits that lasts over 2 weeks,; are taking mineral oil.
Stop use and ask a doctor if you have no bowel movement within 3 days; you have rectal bleeding. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
- Directions
- Other Information
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Inactive ingredients
may contain cirtic acid, D&C red no. 33, D&C yellow no. 10, ethyl vanillin, FD&C blue no. 1, FD&C re no. 40 FD&C yellow no. 6, gelatin, glycerin, edible ink, mannitol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, sorbitol, water.
Distributed by:
Geri-Care Pharmaceuticals Corp.
Brooklyn, NY 11204
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM
docusate sodium capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-590(NDC:57896-401) 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C RED NO. 33 (UNII: 9DBA0SBB0L) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) ETHYL VANILLIN (UNII: YC9ST449YJ) 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) MANNITOL (UNII: 3OWL53L36A) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Product Characteristics Color RED Score no score Shape OVAL Size 14mm Flavor Imprint Code A92 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21695-590-20 20 in 1 BOTTLE 2 NDC:21695-590-30 30 in 1 BOTTLE 3 NDC:21695-590-90 90 in 1 BOTTLE 4 NDC:21695-590-00 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/01/2007 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK
