COLD AND ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]

COLD AND ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]
PDF | XML

NDC 55910-890-24, 55910-890-48
Set ID 9b17fe3a-e279-4bdc-9468-11299d348fb0
Category HUMAN OTC DRUG LABEL
Packager Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredients (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
      • nasal congestion
      • itching of the nose or throat
      • itchy, watery eyes 
    • 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.

    Ask a doctor before use if you have

    • high blood pressure
    • heart disease
    • thyroid disease
    • diabetes
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland 

    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,  
    • avoid alcoholic drinks 
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not improve within 7 days or occur with a fever

    If pregnant or breast-feeding,

    ask a health care professional before use.

    Keep out of reach of children.

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

  • Directions

    • take every 4 hours
    • do not take more than 6 doses in any 24 hour period
    adults and children 12 years of age and older take 1 tablet
    children 6 to under 12 years of age take 1/2 tablet
    children under 6 years of age consult a doctor
    children under 4 years of age do not use
  • Inactive ingredients

    colloidal silicon dioxide, corn starch, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, sodium starch glycolate, stearic acid

  • Questions or comments?

    Call 1-888-309-9030

  • Principal Display Panel

    Compare to active ingredients of Actifed® Cold & Allergy*

    Maximum Strength

    Cold & Allergy

    Chlorpheniramine Maleate 4 mg/Antihistamine

    Phenylephrine HCl 10 mg/Nasal Decongestant

    Pseudoephedrine Free

    • Nasal Congestion • Runny Nose

    • Sneezing • Itchy, Watery Eyes

    Tablets

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Actifed® Cold & Allergy.

    DISTRIBUTED BY DOLGENCORP, LLC

    100 MISSION RIDGE

    GOODLETTSVILLE, TN  37072

  • Product Label

    Chlorpheniramine maleate 4 mg, Phenylephrine HCI 10 mg

    DOLLAR GENERAL Maximum Strength Cold & Allergy

  • INGREDIENTS AND APPEARANCE
    COLD AND ALLERGY  MAXIMUM STRENGTH
    chlorpheniramine maleate, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-890
    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
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize7mm
    FlavorImprint Code T127
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-890-482 in 1 CARTON04/30/201301/26/2024
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:55910-890-2424 in 1 CARTON04/30/201301/26/2024
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/30/201301/26/2024
    Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)

Related Drugs