Label: DAYTIME NIGHTTIME CHILDRENS MULTI-SYMPTOM COLD- dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen, diphenhydramine hcl, phenylephrine hcl kit

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

Drug Label Information

Updated November 26, 2024

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

  • ACTIVE INGREDIENT(S) FOR DAYTIME (in each 5 mL)

    Dextromethorphan HBr 5mg

    Guaifenesin 100 mg

    Phenylephrine HCl 2.5 mg

  • ACTIVE INGREDIENT(S) FOR NIGHTTIME (in each 10 mL)

    Acetaminophen 325 mg
    Diphenhydramine HCl 12.5 mg
    Phenylephrine HCl 5 mg

  • PURPOSE FOR DAYTIME

    Cough Suppressant

    Expectorant

    Nasal decongestant

  • PURPOSE FOR NIGHTTIME

    Pain reliever/fever reducer
    Antihistamine/Cough Suppressant
    Nasal decongestant

  • USE(S)


    DAYTIME

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep
    • nasal congestion due to a cold
    • stuffy nose

    NIGHTTIME


    • temporarily relieves these common cold and flu symptoms:
    • cough
    • sore throat
    • nasal congestion
    • runny nose
    • minor aches and pains
    • headache
    • sinus congestion and pressure
    • sneezing
    • temporarily reduces fever
    • controls cough to help your child get to sleep
  • WARNINGS

    NIGHTTIME


    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:


    • 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

    DAYTIME
    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.

    NIGHTTIME


    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on the skin
    • 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 MAOI drug. If you do not know if your child prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
  • ASK A DOCTOR BEFORE USE IF CHILD HAS


    DAYTIME

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • persistent or chronic cough such as occurs with asthma
    • cough that occurs with too much phlegm (mucus)

    NIGHTTIME


    • liver disease
    • thyroid disease
    • diabetes
    • heart disease
    • high blood pressure
    • glaucoma
    • 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

    NIGHTTIME


    • is taking the blood thinning drug warfarin 
    • taking sedatives or tranquilizers 
  • WHEN USING THIS PRODUCT

    DAYTIME 

    do not use more than directed

    NIGHTTIME

    • do not use more than directed (see Overdose warning)
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • sedatives and tranquilizers may increase drowsiness
  • STOP USE AND ASK DOCTOR IF


    DAYTIME

    • your child gets nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or occur with fever
    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

     These could be signs of a serious illness.

    NIGHTTIME


    • nervousness, dizziness or sleeplessness occur
    • pain, nasal congestion or cough gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back, or occurs with fever, rash or headache that lasts.  These could be signs of a serious condition.
  • KEEP OUT OF REACH OF CHILDREN

    DAYTIME

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

    NIGHTTIME
    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 even if you do not notice any signs or symptoms.

  • DIRECTIONS


    DAYTIME

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • dose as follows or as directed by a doctor

    Age Dose  
    children 6 years to under 12 years  10 mL every 4 hours
    children 4 years to under 6 years  5 mL every 4 hours
    children under 4 years do not use
    • mL = milliliter

    NIGHTTIME


    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed (see Overdose warning)
    • shake well before use
    • do not give more than 5 doses in any 24-hour period
    • if needed, repeat dose every 4 hours while symptoms last
    • do not give more than 5 days unless directed by a doctor
    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • dose as follows or as directed by a doctor
    • mL = milliliter
    • children 6 to under 12 years of age: 10 mL in dosing cup provided.
    • children under 6 years of age: do not use.
  • OTHER INFORMATION


    DAYTIME

    • each 5 mL contains: potassium 5 mg, sodium 5 mg
    • store between 15-30°C (59-86°F)
    • do not refrigerate
    • dosing cup provided


    NIGHTTIME


    • each 10 mL contains: sodium 10 mg
    • store between 15-30°C (59-86°F)
    • do not refrigerate
    • dosing cup provided
  • INACTIVE INGREDIENTS

    DAYTIME

    citric acid anhydrous, D&C red # 33, dextrose, edetate disodium, FD&C blue # 1, FD&C Red #40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum.

    NIGHTTIME
    citric acid anhydrous, edetate disodium, FD&C blue # 1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.

  • QUESTIONS OR COMMENTS?

    call 1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    DAY & NIGHT VALUE PACK

    NDC 49035-938-04

    equateTM

    Compare to Children's Mucinex®Multi-Symptom Cold Active Ingredients*

    Daytime

    Ages 4-12 years

    Children's Multi-Symptom Cold
    Dextromethorphan HBr 5mg   - Cough Suppressant 

    Guaifenesin100mg - Expectorant

    Phenylephrine HCl 2.5 mg - Nasal Decongestant

    •  Relieves Stuffy Nose
    • Soothes Cough
    • Relieves Chest Congestion
    • Thins & loosens Mucus

    Very Berry Flavored 

    Dosage cup included

    NIGHTTIME

    Ages 6-12 yearsChildren's Multi-Symptom ColdAcetaminophen 325mg - Pain reliever/fever reducerDiphenhydramine HCl 12.5mg - Antihistamine/cough suppressant
    Phenylephrine HCl 5 mg - Nasal Decongestant

    • Temporarily reduces fever
    • Soothes cough & sore throat
    • Relieves nasal congestion & sneezing

    Mixed berry flavored Dosage Cup Included
    TWO 4 FL OZ (118 mL) BOTTLES / 8 FL OZ (236 mL) TOTAL
    615-623-combo-sleeve.jpg

  • INGREDIENTS AND APPEARANCE
    DAYTIME NIGHTTIME CHILDRENS MULTI-SYMPTOM COLD 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen, diphenhydramine hcl, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-938
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-938-041 in 1 KIT; Type 0: Not a Combination Product11/26/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 21 BOTTLE 118 mL
    Part 1 of 2
    CHILDRENS MULTI-SYMPTOM COLD DAYTIME 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Item Code (Source)NDC:79903-270
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorBERRY (Verry Berry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    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 DrugM01211/26/2024
    Part 2 of 2
    EQUATE CHILDRENS MULTI SYMPTOM COLD NIGHTTIME 
    acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid
    Product Information
    Item Code (Source)NDC:49035-623
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 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)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorBERRY (Mixed Berry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    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 DrugM01211/26/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/26/2024
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(49035-938)