Label: NIGHTTIME COLD AND FLU LIQUID GELS capsule, liquid filled
DAYTIME COLD AND FLU LIQUID GELS capsule, liquid filled

  • NDC Code(s): 73751-003-01, 73751-009-01
  • Packager: Ocean Healthcare Private Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated November 29, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients (in each LiquiCap) - Purpose

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

  • 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 aretaking the blood thinning drug warfarin.

  • DO NOT USE

    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.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PREGNANCY OR BREAST FEEDING

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

  • PURPOSE

    Active Ingredient-Purpose

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

  • QUESTIONS

    1-732-447-1444

  • STOP USE

    Stop use and ask a doctor if

    • You get nervous, dizzy or sleepless
    • Symptoms get worse or last more than 5 days (children) or 7 days (adults)
    • 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.
  • WHEN USING

    When using this product, do not use more than directed.

  • ACTIVE INGREDIENT

    Active ingredients (in each LiquiCap) - Purpose

    Acetaminophen 325 mg -Pain reliever/fever reducer

    Dextromethorphan HBr 15 mg -Cough suppressant

    Doxylamine succinate 6.25 mg -Antihistamine

  • ASK DOCTOR

    Ask a doctor before use if you have

    • Liver disease
    • Glaucoma
    • Cough that occurs with too much phlegm (mucus)
    • A breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
    • Trouble urinating due to enlarged prostate gland
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • Taking sedatives or tranquilizers
    • Taking the blood thinning drug warfarin
  • DO NOT USE

    Do not use

    • Wth 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.
    • To make a child sleep
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PREGNANCY OR BREAST FEEDING

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

  • PURPOSE

    Active ingredients (in each LiquiCap) -Purpose
    Acetaminophen 325 mg -Pain reliever/fever reducer
    Dextromethorphan HBr 15 mg -Cough suppressant
    Doxylamine succinate 6.25 mg -Antihistamine

  • QUESTIONS

    Questions

    1-732-447-1444

  • STOP USE

    Stop use and ask a doctor if

    • Pain or cough gets worse or lasts 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.
  • WHEN USING

    When using this product

    Do not use more than directed

    • Excitability may occur, especially in children
    • Marked drowsiness may occur
    • Avoid alcoholic drinks
    • Be careful when driving a motor vehicle or operating machinery
    • Alcohol, sedatives, & tranquilizers may increase drowsiness
  • PRINCIPAL DISPLAY PANEL

    Box Label

  • PRINCIPAL DISPLAY PANEL

    Nighttime Cold and Flu Liquid Gels

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME COLD AND FLU LIQUID GELS 
    nighttime cold and flu liquid gels capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73751-009
    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 HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE (UNII: FZ989GH94E)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVAL (Oblong Shape) Size21mm
    FlavorImprint Code AP02
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73751-009-012500 in 1 BAG; Type 0: Not a Combination Product04/06/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only04/06/2020
    DAYTIME COLD AND FLU LIQUID GELS 
    daytime cold and flu liquid gels capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73751-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVAL (Oblong Shaped) Size21mm
    FlavorImprint Code AP01
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73751-003-012500 in 1 BAG; Type 0: Not a Combination Product04/06/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only04/06/2020
    Labeler - Ocean Healthcare Private Limited (873673519)
    Registrant - Sidharth Baid (873673519)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ocean Healthcare Private Limited873673519manufacture(73751-003, 73751-009)