NDC 0280-0921

Alka-Seltzer Plus Day Severe Cold Plus Flu

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

Alka-Seltzer Plus Day Severe Cold Plus Flu is a Oral Powder, For Solution in the Human Otc Drug category. It is labeled and distributed by Bayer Healthcare Llc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 0280-0921_7584d33d-9e87-d19b-e053-2a91aa0a1a28
• NDC: 0280-0921
• Product Type: Human Otc Drug
• Proprietary Name: Alka-Seltzer Plus Day Severe Cold Plus Flu
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
• Dosage Form: Powder, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2014-04-17
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Bayer HealthCare LLC.
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 500 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0280-0921-06

6 PACKET in 1 CARTON (0280-0921-06) > 1 POWDER, FOR SOLUTION in 1 PACKET

• Marketing Start Date: 2014-04-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0280-0921-06 [00280092106]

Alka-Seltzer Plus Day Severe Cold Plus Flu POWDER, FOR SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-04-17

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	500 mg/1

OpenFDA Data

• SPL SET ID: cec51eab-cce3-4965-a14e-a46d953050c4
• Manufacturer:
  • Bayer HealthCare LLC.
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1550968
• UPC Code:
  • 0016500559429

NDC Crossover Matching brand name "Alka-Seltzer Plus Day Severe Cold Plus Flu" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
0280-0921	Alka-Seltzer Plus Day Severe Cold Plus Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-502	COLD AND FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-986	Cold and Flu Severe Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37000-524	DayQuil Severe plus Vicks VapoCool	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
37808-178	DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-474	Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-298	Mucus Relief Cold and Flu All In One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-697	Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-764	Mucus Relief Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37808-164	Mucus Relief Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37808-497	Mucus Relief Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37808-079	Mucus Relief Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-775	Pressure Plus Pain PE Plus Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
15127-184	Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37000-810	Vicks DayQuil	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
37000-811	Vicks DayQuil	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
0363-8591	Walgreens Severe Cold Multi-Symptom For Adults	acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride