Label: ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER- acetaminophen 325 mg and dextromethorphan hbr 10 mg oral liquid day time kids liquid

  • NDC Code(s): 87078-331-01, 87078-331-16
  • Packager: MEDWISE LIFESCIENCES INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 15, 2026

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

  • Active ingredients (in each 10 mL)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

  • Uses

    temporarily relieves common cold/flu symptoms:

    • cough due to minor throat & bronchial irritation
    • sore throat
    • headache
    • minor aches & pains
    • fever
  • Warnings

    Liver warning:This product contains acetaminophen. Severe liver damage may occur if

    • adult takes more than 4 doses (20 mL each) in 24 hrs, which is the maximum daily amount for this product
    • child takes more than 4 doses (10 mL each) in 24 hrs, which is the maximum daily amount for this product
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks every day while using this product

    Allergy Alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away

    Sore throat warning:If sore throat is severe, persists 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 a doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
  • Stop use and ask a doctor if

    • pain or cough gets worse or lasts 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.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as 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
    • do not give more than directed (see liver warning)
    • follow the instruction given on this carton for your eash use
    • mL=mililiter

    Age (years)Dose (Sachet)
    Adults & Children 12 yrs & Over2 sachets (20 mL*) every 4 hrs
    Children 6 to under 12 yrs1 sachet (10 mL*) every 4 hrs
    Children 4 to under 6 yrsask a doctor
    Children under 4 yrsdo not use

  • Other Information

    • store between 20 - 25° C (68-77° F)
    • Do not use if carton or sachet is torn, broken or punctured.
  • Inactive Ingredients

    citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum, edetate sodium.

  • Question or Comments?

    Call 1-516-675-8915

  • PRINCIPAL DISPLAY PANEL

    NDC 87078-331-16

  • INGREDIENTS AND APPEARANCE
    ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER 
    acetaminophen 325 mg and dextromethorphan hbr 10 mg oral liquid day time kids liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:87078-331
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM SACCHARIN (UNII: SB8ZUX40TY)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:87078-331-1616 in 1 CARTON05/15/2026
    1NDC:87078-331-0110 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/15/2026
    Labeler - MEDWISE LIFESCIENCES INC. (140161518)