Label: PROMOLAXIN- docusate sodium tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68258-4987-0 - Packager: Dispensing Solutions, Inc.
- This is a repackaged label.
- Source NDC Code(s): 27495-012
- 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 October 30, 2013
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- Ask a doctor before use if you have
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of Reach of Children.
- Directions
- Other information
- Inactive ingredients
- Questions?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROMOLAXIN
docusate sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68258-4987(NDC:27495-012) 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 HYPROMELLOSES (UNII: 3NXW29V3WO) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score no score Shape ROUND Size 11mm Flavor Imprint Code GPI;S1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68258-4987-0 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/15/2011 Labeler - Dispensing Solutions, Inc. (066070785) Registrant - PSS World Medical, Inc. (101822682) Establishment Name Address ID/FEI Business Operations Dispensing Solutions, Inc. 066070785 relabel(68258-4987) , repack(68258-4987)