Label: EQUATE CHILDRENS MULTI SYMPTOM COLD NIGHTTIME- acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 20, 2024

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

  • ACTIVE INGREDIENTS (in each 10 mL)

    Acetaminophen 325 mg

    Diphenhydramine HCl 12.5 mg

    Phenyephrine HCl 5 mg

  • PURPOSE

    Pain reliever / fever reducer

    Antihistamine/Cough Suppressant

    Nasal decongestant

  • USE(S)

    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

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


    • more than 5 doses in 24 hous, 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

    • 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 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 THE CHILD HAS

    • 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 

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

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

    • 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 rash or headache that lasts. These could be signs of a serious condition.
  • KEEP OUT OF REACH OF CHILDREN

    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

    • 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

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

    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

    1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    NDC 49035-623-03

    equate

    Compare to Children's Mucinex® Nighttime Multi-Symptom Cold active ingredients*

    Children's 

     MULTI-SYMPTOMS COLD 
    NIGHTTIME

    Acetaminophen 325 mg
    Pain reliever/Fever Reducer

    Diphenhydramine HCl 12.5 mg

    Antihistamine/Cough Suppressant 

    Phenylephrine HCl 5 mg

    Nasal Decongestant

    AGES 6 to 12 YEARS



    • Relieves headache and fever
    • Soothes cough
    • Relieves nasal congestion 
    • Relieves runny nose and sneezing

     Mixed Berry Flavored



     4 FL OZ (118 mL)

    623-Equate-4oz


  • INGREDIENTS AND APPEARANCE
    EQUATE CHILDRENS MULTI SYMPTOM COLD NIGHTTIME 
    acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem 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
    1NDC:49035-623-031 in 1 CARTON08/01/2017
    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 DrugM01208/01/2017
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(49035-623)