Label: DOCUSATE SODIUM 100MG- docusate sodium capsule, liquid filled
- NDC Code(s): 53345-029-01, 53345-029-02
- Packager: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 25, 2024
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each softgel)
- Purpose
- Uses
-
Warnings
Ask a doctor before use if you have
- stomach pain, nausea or vomitting
- a sudden change in bowel habits that lasts more than 2 weeks
- Directions
- Other information
- Inactive ingredients
-
PRINCIPAL DISPLAY PANEL - Shipping Label
DOCUSATE SODIUM CAPSULES, 100 mg
Quantity : 20000 Capsules
NDC. No : 53345-029-01IMPORTANT:
Inspect immediate upon receipt.
This is a bulk shipment, intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
Store at 15-30°C (59-86°F)
CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING -
PRINCIPAL DISPLAY PANEL - Shipping Label
DOCUSATE SODIUM CAPSULES, 100 mg
Quantity : 15000 Capsules
NDC. No : 53345-029-02IMPORTANT:
Inspect immediate upon receipt.
This is a bulk shipment, intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
Store at 15-30°C (59-86°F)
CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING -
INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM 100MG
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53345-029 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 (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color red Score no score Shape CAPSULE (OVAL) Size 13mm Flavor Imprint Code 655 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53345-029-01 1 in 1 BOX 01/28/2015 1 20000 in 1 BAG; Type 0: Not a Combination Product 2 NDC:53345-029-02 1 in 1 BOX 01/28/2015 2 15000 in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007 01/28/2015 Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. (421293287) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. 421293287 manufacture(53345-029)