Label: SIGNATURE CARE CHILDRENS COLD AND COUGH- brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl solution

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

Drug Label Information

Updated November 17, 2024

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

View All Sections
  • Active ingredients (in each 10 mL)

    Brompheniramine maleate, USP 2 mg

    Dextromethorphan HBr, USP 10 mg

    Phenylephrine HCl, USP 5 mg

  • Purposes

    Antihistamine

    Cough suppressant

    Nasal decongestant

  • Uses

    •
    temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    •
    temporarily relieves these symptoms due to hay fever (allergic rhinitis):
    •
    runny nose
    •
    sneezing
    •
    itchy, watery eyes
    •
    itching of the nose or throat
    •
    temporarily restores freer breathing through the nose
  • Warnings

    Do not use

    •
    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 sleepy

    Ask a doctor before use if you have

    •
    heart disease
    •
    high blood pressure
    •
    thyroid disease
    •
    diabetes
    •
    trouble urinating due to an enlarged prostate gland
    •
    glaucoma
    •
    cough that occurs with too much phlegm (mucus)
    •
    a breathing problem such as emphysema or chronic bronchitis
    •
    cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    •
    do not use more than directed
    •
    may cause marked drowsiness
    •
    avoid alcoholic beverages
    •
    alcohol, sedatives, and tranquilizers may increase drowsiness
    •
    be careful when driving a motor vehicle or operating machinery
    •
    excitability may occur, especially in children

    Stop use and ask a doctor if

    •
    you get nervous, dizzy, or sleepless
    •
    symptoms do not get better within 7 days or are accompanied by fever
    •
    cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 right away (1-800-222-1222).

  • Directions

    •
    do not take more than 6 doses in any 24-hour period
    •
    measure only with dosage cup provided
    •
    keep dosage cup with product
    •
    mL = milliliter

    age

    dose

    adults and children 12 years and over

    20 mL every 4 hours

    children 6 to under 12 years

    10 mL every 4 hours

    children under 6 years

    do not use
  • Other information

    •
    each 10 mL contains: sodium 4 mg
    •
    store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution

  • Questions or comments?

    1-888-723-3929

  • Principal Display Panel

    AGES 6 YRS. & OLDER

    Children’s Cold & Cough

    Brompheniramine Maleate 2mg - Antihistamine

    Dextromethorphan HBr 10mg – Cough Suppressant

    Phenylephrine HCl 5mg – Nasal Decongestant

    GRAPE FLAVOR

    Compare to Children’s Dimetapp® Cold & Cough active ingredients

    Relieves Nasal Symptoms:

    Stuffy Nose

    Runny Nose

    Sneezing

    Plus Other Symptoms:

    Itchy, Watery Eyes

    Cough

    Alcohol Free

    Gluten Free

    4 FL OZ (118mL)

    Signature Care Children's Cold & Cough image
  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE CHILDRENS COLD AND COUGH 
    brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-082
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 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)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorPURPLE (Clear bluish-red) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-082-261 in 1 CARTON02/05/2016
    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 DrugM01202/05/2016
    Labeler - Safeway (009137209)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!