ALKA-SELTZER PLUS DAY AND NIGHT COLD AND FLU FORMULA (Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Doxylamine Succinate) Kit [Bayer HealthCare LLC.]

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ALKA-SELTZER PLUS DAY AND NIGHT COLD AND FLU FORMULA (Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Doxylamine Succinate) Kit [Bayer HealthCare LLC.]

ALKA-SELTZER PLUS  DAY AND NIGHT COLD AND FLU FORMULA acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and doxylamine succinate kit

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-1126

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-1126-20 1 in 1 CARTON 10/30/2013 08/31/2018 2 NDC:0280-1126-40 1 in 1 CARTON; Type 0: Not a Combination Product 10/30/2013 08/31/2018

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 12  Part 2 1 BLISTER PACK 8  Part 3 2 BLISTER PACK 24  Part 4 2 BLISTER PACK 16

Part 1 of 4 ALKA-SELTZER PLUS  COLD AND FLU FORMULA DAY acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

Product Information Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8)   FD&C RED NO. 40 (UNII: WZB9127XOA)   GELATIN (UNII: 2G86QN327L)   GLYCERIN (UNII: PDC6A3C0OX)   POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)   POVIDONES (UNII: FZ989GH94E)   PROPYLENE GLYCOL (UNII: 6DC9Q167V3)   WATER (UNII: 059QF0KO0R)   SHELLAC (UNII: 46N107B71O)   SODIUM HYDROXIDE (UNII: 55X04QC32I)   TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics Color orange Score no score Shape OVAL Size 20mm Flavor Imprint Code AS;DC Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/30/2013 08/31/2018

Part 2 of 4 ALKA-SELTZER PLUS  COLD AND FLU FORMULA NIGHT acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled

Product Information Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD)   D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)   GELATIN (UNII: 2G86QN327L)   GLYCERIN (UNII: PDC6A3C0OX)   POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)   POVIDONES (UNII: FZ989GH94E)   PROPYLENE GLYCOL (UNII: 6DC9Q167V3)   WATER (UNII: 059QF0KO0R)   SHELLAC (UNII: 46N107B71O)   SODIUM HYDROXIDE (UNII: 55X04QC32I)   TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics Color green Score no score Shape OVAL Size 20mm Flavor Imprint Code AS;Nite Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/30/2013 08/31/2018

Part 3 of 4 ALKA-SELTZER PLUS  COLD AND FLU FORMULA DAY acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

Product Information Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8)   FD&C RED NO. 40 (UNII: WZB9127XOA)   GELATIN (UNII: 2G86QN327L)   GLYCERIN (UNII: PDC6A3C0OX)   POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)   POVIDONES (UNII: FZ989GH94E)   PROPYLENE GLYCOL (UNII: 6DC9Q167V3)   WATER (UNII: 059QF0KO0R)   SHELLAC (UNII: 46N107B71O)   SODIUM HYDROXIDE (UNII: 55X04QC32I)   TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics Color orange Score no score Shape OVAL Size 20mm Flavor Imprint Code AS;DC Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/30/2013 08/31/2018

Part 4 of 4 ALKA-SELTZER PLUS  COLD AND FLU FORMULA NIGHT acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled

Product Information Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD)   D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)   GELATIN (UNII: 2G86QN327L)   GLYCERIN (UNII: PDC6A3C0OX)   POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)   POVIDONES (UNII: FZ989GH94E)   PROPYLENE GLYCOL (UNII: 6DC9Q167V3)   WATER (UNII: 059QF0KO0R)   SHELLAC (UNII: 46N107B71O)   SODIUM HYDROXIDE (UNII: 55X04QC32I)   TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics Color green Score no score Shape OVAL Size 20mm Flavor Imprint Code AS;Nite Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/30/2013 08/31/2018

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/30/2013 08/31/2018