NDC 55319-616

Multi-Symptom Cold Flu and Sore Throat Maximum Strength

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Multi-Symptom Cold Flu and Sore Throat Maximum Strength is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Family Dollar Services Inc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID55319-616_5273f467-1881-4ca7-9bb0-5965efb00603
NDC55319-616
Product TypeHuman Otc Drug
Proprietary NameMulti-Symptom Cold Flu and Sore Throat Maximum Strength
Generic NameAcetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-04-07
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameFamily Dollar Services Inc
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 55319-616-09

2 BLISTER PACK in 1 PACKAGE (55319-616-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2013-04-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55319-616-09 [55319061609]

Multi-Symptom Cold Flu and Sore Throat Maximum Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-04-07

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:9ffa3a29-0e19-4c6b-abee-7f76071990d9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1110988
  • NDC Crossover Matching brand name "Multi-Symptom Cold Flu and Sore Throat Maximum Strength" or generic name "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    49035-616Multi-Symptom Cold Flu and Sore Throat Maximum StrengthMulti-Symptom Cold Flu and Sore Throat Maximum Strength
    55319-616Multi-Symptom Cold Flu and Sore Throat Maximum StrengthMulti-Symptom Cold Flu and Sore Throat Maximum Strength
    0113-7603Basic Care Daytime Cold and Flu Severeacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
    0113-7303basic care mucus relief cold flu and sore throatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0640Cold and FluAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0299good sense cold and flu severeAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0234good sense cold head congestionAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0381Good Sense Mucus ReliefAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-1913good sense mucus relief cold flu and sore throatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0579good sense severe coldAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0548Good Sense Severe Daytimeacetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
    0113-0603Good Sense Severe Daytime Cold and Fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
    0113-9007Good Sense Severe Tussin CF MaxAcetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
    0363-0616Mucus ReliefAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0538Mucus Relief Cold Flu Sore ThroatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0719Mucus Relief Cold Flu Sore ThroatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0372Mucus Relief PlusAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0410Mucus Relief Severe ColdAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0503Severe ColdAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0603Severe Cold and Fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
    0363-0524Sinus ReliefAcetaminophen, Dextromethorphan HBR, Guaifenesin, Phenylephrine HCl
    0067-8145Theraflu ExpressMax Severe Cold and Flu CapletsAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0067-8132Theraflu ExpressMax Severe Cold and Flu SyrupAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0051Wal Tussin CF MaxAcetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl

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