NDC 57344-134

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

Acetaminophen, Dextromethorphan Hydrobromide, 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; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID57344-134_7e5d9f1f-ff8b-ca1b-e053-2991aa0a20f4
NDC57344-134
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2012-12-22
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAAA Pharmaceutical, Inc.
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 57344-134-03

2 BLISTER PACK in 1 CARTON (57344-134-03) > 10 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date2012-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57344-134-02 [57344013402]

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-22
Marketing End Date2012-12-23

NDC 57344-134-03 [57344013403]

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-22
Marketing End Date2012-12-23

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:e4739c45-807f-4b94-a264-6164272740ca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1098435

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

    NDCBrand NameGeneric Name
    57344-159Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HydrochlorideAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    57344-134Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HydrochlorideAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    57344-163Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HydrochlorideAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    57344-136Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HydrochlorideAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    0280-0921Alka-Seltzer Plus Day Severe Cold Plus FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    0280-0061Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermaxacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    0280-0507Alka-Seltzer Plus Severe Sinus Cold and CoughAcetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride
    0113-7902basic care daytime cold and fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    0363-4661Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    0363-9974Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    36800-502COLD AND FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    24385-066good neighbor pharmacy coldAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    0113-4500good sense sever day time cold and fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    36800-474Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    11822-1576Maximum Strength Severe Sinus Pressure, Pain and Cough ReliefAcetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride
    36800-298Mucus Relief Cold and Flu All In OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-697Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    0031-8751Robitussin Severe Multi-Symptom Cough Cold Fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    0363-1940severe cold and fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    15127-184Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    0363-4150Severe Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    11822-0940severe vapor ice cold and flu reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    21130-811signature care daytime severe cold and flu reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    36800-581topcare day time cold and fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    36800-747Topcare Mucus Reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    0363-6300Walgreen Severe Multi-Symptom Cough Cold Fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    0363-8591Walgreens Severe Cold Multi-Symptom For Adultsacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
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