CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]

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  • CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]

CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]
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NDC 57344-158-02
Set ID b413630b-de50-4e32-bf80-05fae8e5eb55
Category HUMAN OTC DRUG LABEL
Packager AAA Pharmaceutical, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purpose
    Chlorpheniramine maleate 4 mgAntihistamine
    Phenylephrine HCl 10 mgNasal 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.

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

    • do not exceed recommended dosage
    • 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

    • nervousnous, dizziness, or sleeplessness occurs
    • symptoms do not improve 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 hours; do not take more than 6 tablets in 24 hours
    • children under 12 years of age: do not use this product in children under 12 years of age
  • Other information

    • store at 20°-25°C (68°-77°F)
    • retain carton for complete product information
  • Inactive ingredients

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

  • Questions or comments?

    1-844-705-4384

  • PRINCIPAL DISPLAY PANEL

    RESTORE u

    NDC 57344-158-02

    †COMPARE TO THE ACTIVE INGREDIENT IN ACTIFED® COLD + ALLERGY

    Cold + Allergy

    Chlorpheniramine Maleate, Phenylephrine HCl

    Antihistamine, Nasal Decongestant

    One Tablet Dose

    Relieves: • Nasal Congestion • Sneezing • Runny Nose • Itchy, Watery Eyes

    Actual Size

    24 TABLETS

    image description

  • INGREDIENTS AND APPEARANCE
    CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE 
    chlorpheniramine maleate and phenylephrine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-158
    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, DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code T127
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57344-158-021 in 1 CARTON06/01/201901/31/2022
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/01/201901/31/2022
    Labeler - AAA Pharmaceutical, Inc. (181192162)
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