NDC 57344-119

Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride

Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride

Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Aaa Pharmaceutical, Inc.. The primary component is Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 57344-119_8cefa83b-202c-41d0-9965-ed615ffce5eb
• NDC: 57344-119
• Product Type: Human Otc Drug
• Proprietary Name: Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride
• Generic Name: Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-12-28
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: AAA Pharmaceutical, Inc.
• Substance Name: ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 57344-119-05

2 BLISTER PACK in 1 CARTON (57344-119-05) > 12 TABLET, COATED in 1 BLISTER PACK

• Marketing Start Date: 2012-12-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57344-119-05 [57344011905]

Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride TABLET, COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-12-28
• Inactivation Date: 2020-01-31

NDC 57344-119-02 [57344011902]

Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride TABLET, COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-12-28
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 2a9d2ec5-3b62-49a6-9a8f-e2aa9359bdba
• Manufacturer:
  • AAA Pharmaceutical, Inc.
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 495W7451VQ

NDC Crossover Matching brand name "Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride" or generic name "Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
57344-119	Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride	Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride
36800-575	Cold and Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37808-775	Cold Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
46122-415	Cold Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41250-275	COLD RELIEF SEVERE HEAD CONGESTION	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-793	Head Congestion plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41163-712	Head Congestion Plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41250-573	head congestion plus mucus PE	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
47682-168	Medique CCP Caffeine Free	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
41250-273	Mucus and Sinus PE	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41250-267	mucus relief sinus severe congestion and pain	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
46122-712	Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37808-367	Mucus Relief Sinus Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41163-512	Pressure and Pain PE Plus Mucus	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-773	Pressure Plus Pain PE Plus Mucus	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
49738-788	PRESSURE plus PAIN plus MUCUS	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-505	Sinus Congestion and Pain Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
49348-117	Sinus Congestion and Pain Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
46122-229	Sinus Relief Congestion and Pain Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41250-219	sinus severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
46122-412	Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
49738-119	Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
29485-8055	TYLENOL SINUS SEVERE	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
29485-8057	TYLENOL SINUS SEVERE	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE