Label: ALLERGY RELIEF- chlorpheniramine maleate tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 67510-0159-0, 67510-0159-2, 67510-0159-4 - Packager: Kareway Product, 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 February 15, 2013
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
- Warnings
- Ask a doctor or pharmacist before use if you are
- When using this product
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Package label
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
chlorpheniramine maleate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0159 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 MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 68401960MK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSES (UNII: 3NXW29V3WO) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) ETHANETHIOL (UNII: M439R54A1D) Product Characteristics Color blue Score no score Shape ROUND Size 9mm Flavor Imprint Code BT Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0159-2 2 in 1 BOX 1 12 in 1 BLISTER PACK 2 NDC:67510-0159-0 2 in 1 BOX 2 10 in 1 BLISTER PACK 3 NDC:67510-0159-4 4 in 1 BOX 3 12 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/18/2011 Labeler - Kareway Product, Inc. (121840057)