Label: GENCARE DAYTIME COLD AND FLU SOFTGEL- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

  • NDC Code(s): 72090-005-01
  • Packager: Pioneer Life Sciences, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 7, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active ingredients (in each softgel)

    Acetaminophen 325mg

    Dextromethorphan HBr 10mg

    Phenylephrine HCl 5mg

  • Purpose

    Acetaminophen 325mg.....................Pain reliever/fever reducer
    Dextromethorphan HBr 10mg..................... Cough suppressant
    Phenylephrine HCl 5mg ............................. Nasal decongestant

  • Uses:

    temporarily relieves common cold/flu symptoms:
    ■ nasal congestion

    ■ cough due to minor throat & bronchial irritation

    ■ sore throat

    ■ headache

    ■ minor aches & pains

    ■ fever

  • Warning

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
    ■ more than 4 doses in 24 hrs, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily while using this product.

    Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting,consult a doctor promptly.

  • Do not use:

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist 
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or
      Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • ASK DOCTOR

    Ask a doctor before use if you have

    ■ liver disease

    ■ heart disease

    ■ thyroid disease

    ■ diabetes

    ■ high blood pressure

    ■ trouble urinating due to enlarged prostate gland

    ■ cough that occurs with too much phlegm (mucus)

    ■ persistent or chronic cough as occurs with smoking, asthma, or emphysema

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are
    • taking the blood thinning drug warfarin
  • WHEN USING

    When using this product do not use more than directed.

  • STOP USE

    Stop use and ask a doctor if
    • you get nervous, dizzy or sleepless
    • pain, nasal congestion or cough get worse or last more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for
    adults & for children even if you do not notice any signs or symptoms.

  • Directions

    ■ take only as directed

    ■ do not exceed 4 doses per 24 hrs. 

     Adults and children 12 yrs and overtake 2 softgels with water every 4 hrs. 
     Children 4 to under 12 yrs  ask a doctor
     Children under 4 yrs do not use

  • Other information

    ■ store at room temperature

  • Inactive ingredients

    Polyethylene Glycol400, Propylene Glycol, Povidone, Gelatin, Sorbitol Sorbitan Anhydrous, Glycerin, Allura Red, FD & C Yellow 6/Sunset Yellow, Titanium Dioxide.

  • Questions or Comments?

    Call 1-732-698-5070 Mon-Fri, 9am-5pm EST or visit: www.gencare.health.

  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by PROCTER & GAMBLE, owner of the registered trademark Vicks® Dayquil™ Cold and Flu LiquiCaps™.

  • SPL UNCLASSIFIED SECTION

    Distributed by: Gencare Consumer Products, LLC
    40E Cotters Ln, Suite A, East Brunswick, NJ 08816

  • NDC 72090-005-01- 48 Softgels

    PL0163 Rev00 DayTime Cold & Flu - 48ct

  • INGREDIENTS AND APPEARANCE
    GENCARE DAYTIME COLD AND FLU SOFTGEL 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE (UNII: FZ989GH94E)  
    Gelatin (UNII: 2G86QN327L)  
    Sorbitol (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapecapsuleSize19mm
    FlavorImprint Code A09
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72090-005-0148 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/08/2023
    Labeler - Pioneer Life Sciences, LLC (014092742)