Label: PROMOLAXIN- docusate sodium tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 42549-693-71 - Packager: STAT Rx USA LLC
- 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 September 19, 2012
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- Download DRUG LABEL INFO: PDF XML
- 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?
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL - PROMOLAXIN 100 MG TABLETS
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INGREDIENTS AND APPEARANCE
PROMOLAXIN
docusate sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42549-693(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:42549-693-71 100 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 - STAT Rx USA LLC (786036330) Registrant - PSS World Medical Inc. (101822682) Establishment Name Address ID/FEI Business Operations STAT Rx USA LLC 786036330 relabel(42549-693) , repack(42549-693)