Label: CHILDRENS COLD COUGH AND SORE THROAT MIXED BERRY- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 1, 2024

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

  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredients Purpose
    (in each 10 mL)
    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

  • PURPOSE

    Purpose

    Acetaminophen ……....…….... Pain reliever/fever reducer
    Dextromethorphan HBr …....Cough suppressant
    Guaifenesin ………….....…..…. Expectorant
    Phenylephrine HCI …...……….Nasal decongestant

  • INDICATIONS & USAGE

    Uses
    • temporarily relieves these common cold and flu symptoms:
    • nasal congestion • stuffy nose • minor aches and pains • sore throat • headache • fever
    • cough due to minor throat and bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tube

  • WARNINGS

    Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include • skinreddening • blisters • rash. If 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. • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if your child has
    • Iiver disease • heart disease • high blood pressure • thyroid disease • diabetes • a breathing problem such as chronic bronchitis • persistent or chronic cough such as occurs with asthma • cough that occurs with too much phlegm (mucus)

    Ask a doctor or pharmacist before use if • your child is taking the blood thinning drug warfarin.

    When using this productdo not use more than directed (see Overdose warning)

    Stop use and ask a doctor if
    • redness or swelling is present
    • nervousness, dizziness or sleeplessness occur
    • new symptoms occur
    • pain, nasal congestion or cough gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    • cough comes back, or occurs with rash or headache that lasts.
    These could be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get
    medical help or contact a Poison Control Center right
    away.

  • OVERDOSAGE

    Overdose warning
    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or
    contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if
    you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions
    • do not use more than directed (see Overdose warning)
    • shake well before using
    • do not use more than 5 doses in any 24-hour period
    • if needed, repeat dose every 4 hours while symptoms last
    • do not use more than 5 days unless directed by a doctor
    • use dosage cup

    Age                                         Dose
     Children 6 to under 12 years of age 10 mL every 4 hours
    Children under 6 years of age Do not use

  • OTHER SAFETY INFORMATION

    Other information
    each 10 mL contains: sodium 5 mg
    store between IS-30°C (59-86°F)
    do not refrigerate
    dosage cup provided

  • INACTIVE INGREDIENT

    Inactive ingredients
    anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate,
    purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum

  • QUESTIONS

    Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944

  • Maximum Strength MAX COLD & SINUS

    AP SAFE                       NDC 76281-519-24

    Compare to Mucinex® FAST-MAX™ Cold & Sinus
    Active ingredients*

    Children's

    Cold, Cough 

    & Sore Throat

    Pain reliever/Fever Reducer
    Cough Suppresant
    Expectorant
    Nasal decongestant

    For Ages 6 to 12

    Mixed Berry Flavor

    4 FL OZ ( 118 mL)

    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    Manufactured by:
    AptaPharma Inc.,
    1533 Union Ave.
    Pennsauken, NJ 08110

    * This product is not manufactured or distributed by Reckitt

    Benckiser Inc., distributor ofchildren's Mucinex® Cold,

    Cough & Sore Throat liquid.

    519 4 Oz

    519 4 Oz Botl

    res

  • INGREDIENTS AND APPEARANCE
    CHILDRENS COLD COUGH AND SORE THROAT MIXED BERRY 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-519
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-519-241 in 1 CARTON01/30/2024
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/30/2024
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-519)