NDC 51013-170

Maximum Strength Congestion and Headache

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

Maximum Strength Congestion and Headache is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Puracap Pharmaceutical Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

• Product ID: 51013-170_63ce0194-6f37-4ce7-a32a-fe6bbc94ac7c
• NDC: 51013-170
• Product Type: Human Otc Drug
• Proprietary Name: Maximum Strength Congestion and Headache
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2016-06-10
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: PuraCap Pharmaceutical LLC
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 51013-170-14

2 BLISTER PACK in 1 CARTON (51013-170-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

• Marketing Start Date: 2016-06-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51013-170-14 [51013017014]

Maximum Strength Congestion and Headache CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-06-10

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 8fbf1ce1-a7cf-4c9f-a260-6740088b44b6
• Manufacturer:
  • PuraCap Pharmaceutical LLC
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1086997

NDC Crossover Matching brand name "Maximum Strength Congestion and Headache" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
0363-5556	Maximum Strength Congestion and Headache	Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
0363-9019	Maximum Strength Congestion and Headache	Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
51013-170	Maximum Strength Congestion and Headache	Maximum Strength Congestion and Headache
0280-1590	Alka-Seltzer Plus Maximum Strength Day Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0280-1630	Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gels	acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
0280-1221	Alka-Seltzer Plus Severe Sinus Congestion and Cough Liquid Gels Day	Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
0113-7656	basic care daytime cold and flu	acetaminophen, dextromethorphan hydrobromide, Phenylephrine hydrochloride
21130-598	Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-650	Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
11868-311	Cold Preparation	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
11868-466	Cold Preparation	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-468	Day time	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
15127-466	Day Time Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0904-5763	Day Time Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-866	Day Time Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0363-1140	Daytime Cold and Flu	acetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
11822-1583	Daytime Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0363-1000	Daytime Cold and Flu Relief	acetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0363-1003	Daytime Cold and Flu Relief	acetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-311	Daytime Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-471	Daytime Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0113-0096	good sense flu and severe cold and cough	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
11822-0096	severe cold cough and flu relief	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride