Label: DOCUSATE SODIUM capsule, liquid filled
- NDC Code(s): 60687-129-01, 60687-129-11
- Packager: American Health Packaging
- 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.
Updated October 5, 2020
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- Active ingredient (in each softgel)
Do not use
- if you are currently taking mineral oil, unless directed by a doctor
- when abdominal pain, nausea or vomiting are present unless directed by a doctor
- for longer than one week unless directed by a doctor
Ask a doctor before use 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 or you fail to have a bowel movement after use of a laxative. This may indicate a serious condition.
If pregnant or breast-feeding, ask a health care professional before use.
- KEEP OUT OF REACH OF CHILDREN
- Other information
FD&C Red #40, FD&C Yellow #6, Gelatin USP, Glycerin USP, Polyethylene Glycol 400 NF, Purified Water USP, Sorbital USP
The drug product contained in this package is from NDC # 61301-8001, SWISSCAPS Romania srl.
American Health Packaging
2550 John Glenn Avenue, Suite A
Columbus, OH 43217
- Principal Display Panel – Carton – 100 mg
- Principal Display Panel - Blister – 100 mg
INGREDIENTS AND APPEARANCE
docusate sodium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60687-129 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 FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color red (Reddish) Score no score Shape OVAL Size 12mm Flavor Imprint Code SCU1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60687-129-01 100 in 1 BOX, UNIT-DOSE 11/25/2015 1 NDC:60687-129-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 11/25/2015 Labeler - American Health Packaging (929561009) Registrant - Swiss Caps Romania (565466997) Establishment Name Address ID/FEI Business Operations Swiss Caps Romania 565466997 manufacture(60687-129) Establishment Name Address ID/FEI Business Operations American Health Packaging 929561009 repack(60687-129)