NDC 63940-342

Severe Cold and Flu

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

Severe Cold and Flu is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Harmon Stores Inc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 63940-342_9483de11-ec9d-5dda-e053-2a95a90adcb5
• NDC: 63940-342
• Product Type: Human Otc Drug
• Proprietary Name: Severe Cold and Flu
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-09-11
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Harmon Stores Inc.
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63940-342-03

2 BLISTER PACK in 1 CARTON (63940-342-03) > 12 TABLET, COATED in 1 BLISTER PACK

• Marketing Start Date: 2018-09-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63940-342-03 [63940034203]

Severe Cold and Flu TABLET, COATED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-09-11

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 9483de11-ec9c-5dda-e053-2a95a90adcb5
• Manufacturer:
  • Harmon Stores Inc.
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1110988
• UPC Code:
  • 0099581911713

NDC Crossover Matching brand name "Severe Cold and Flu" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
0363-0603	Severe Cold and Flu	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0363-0623	severe cold and flu	Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
0363-0763	Severe Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
0363-1597	Severe Cold and Flu	acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
0363-1940	severe cold and flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
0363-5553	SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
0363-8994	SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
0363-8995	SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
0363-9896	SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
11673-640	severe cold and flu	acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
11673-649	severe cold and flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl
11673-677	Severe Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
68998-163	Severe Cold and Flu	Severe Cold and Flu
15127-184	Severe Cold and Flu	Severe Cold and Flu
37808-619	severe cold and flu	severe cold and flu
42507-603	Severe Cold and Flu	Severe Cold and Flu
49035-945	Severe Cold and Flu	Severe Cold and Flu
56062-319	severe cold and flu	severe cold and flu
62011-0241	Severe Cold and Flu	Severe Cold and Flu
63868-003	Severe Cold and Flu	Severe Cold and Flu
69842-972	Severe Cold and Flu	Severe Cold and Flu
63940-342	Severe Cold and Flu	Severe Cold and Flu
70000-0525	Severe Cold and Flu	Severe Cold and Flu
0280-0921	Alka-Seltzer Plus Day Severe Cold Plus Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
0363-8591	Walgreens Severe Cold Multi-Symptom For Adults	acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride