Label: CHLORPHENIRAMINE MALEATE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 66424-034-01, 66424-034-10 - Packager: SDA Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 15, 2011
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- Official Label (Printer Friendly)
- Active ingredient(in each tablet)
- Uses
- Warnings
- Ask a doctor before use if you have,
- Ask a doctor or pharmacist before use if you
- When using this product
- If pregnant or breast feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients: corn starch, croscarmellose sodium, D&C yellow # 10 aluminum lake 14-18%, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide
- Questions:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHLORPHENIRAMINE MALEATE
chlorpheniramine maleate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66424-034 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate 4 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color yellow Score no score Shape ROUND Size 8mm Flavor Imprint Code PH012 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66424-034-01 100 in 1 BOTTLE, PLASTIC 2 NDC:66424-034-10 1000 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/19/2010 Labeler - SDA Laboratories, Inc. (948067889) Registrant - Pharbest Pharmaceuticals, Inc. (557054835) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc. 557054835 manufacture