Label: DG HEALTH COLD AND ALLERGY- chlorpheniramine maleate, phenylephrine hcl tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 30, 2009

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

View All Sections
  • Active ingredient (in each tablet)

    Chlorpheniramine maleate 4 mg

    Phenylephrine HCl 10 mg

  • Purpose

    Antihistamine

    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • nasal congestion
    • itching of the nose or throat
    • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
    • nasal congestion
  • 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
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

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

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or occur with fever

    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

    adults and children 12 years and over
    • take 1 tablet every 4 to 6 hours
    • do not take more than 6 tablets in 24 hours
    children under 12 yearsdo not use this product in children under 12 years of age
  • Inactive ingredients

    carnauba wax, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-888-309-9030

  • Principal Display Panel

    Compare to active ingredients of Actifed® Cold & Allergy

    Cold & Allergy

    Chlorpheniramine Maleate, Antihistamine

    Phenylephrine HCl, Nasal Decongestant

    Nasal Congestion

    Runny Nose

    Sneezing

    Itchy, Watery Eyes

    See New Dosing Directions

    One Tablet Dose

    Cold & Allergy Carton

    Cold & Allergy Carton

  • INGREDIENTS AND APPEARANCE
    DG HEALTH COLD AND ALLERGY 
    chlorpheniramine maleate, phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-139
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code L358
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-139-621 in 1 CARTON
    124 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/26/2010
    Labeler - Dolgencorp Inc (068331990)
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!