Label: DOCUSATE SODIUM 100MG TWO-TONE- docusate sodium capsule, liquid filled
- NDC Code(s): 53345-023-01
- Packager: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
- 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 November 7, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each capsule)
- 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 movements that lasts over 2 weeks
- Directions
- Other information
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL - Shipping Label
DOCUSATE SODIUM CAPSULES, 100 mg
Quantity : 20000 Capsules
NDC. No : 53345-023-01IMPORTANT:
1.Inspect immediate upon receipt.
2.This is a bulk shipment intended for further processing only.
3.Protect from heat, humidity, and light. Do not refrigerate.
4.Store at 15-30°C (59-86°F)CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM 100MG TWO-TONE
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53345-023 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) D&C RED NO. 33 (UNII: 9DBA0SBB0L) 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, white (Two-Tone) Score no score Shape CAPSULE (OVAL) Size 13mm Flavor Imprint Code 657 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53345-023-01 1 in 1 BOX 08/11/2014 1 20000 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 not final part334 08/11/2014 Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. 421293287 MANUFACTURE(53345-023) , ANALYSIS(53345-023)