Label: SINUS AND ALLERGY- chlorpheniramine maleate and phenylephrine hydrochloride tablet 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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

  • Active ingredients (in each tablet)

    Chlorpheniramine maleate 4 mg

    Phenylephrine HCl 10 mg

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  • Purpose

    Antihistamine

    Nasal decongestant

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  • 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
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  • 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
    • glaucoma
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • thyroid disease
    • 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 use more than directed
    • drowsiness may occur
    • avoid alcoholic drinks
    • excitability may occur, especially in children
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • 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 are accompanied by a 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

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  • Directions

    • take every 4 hours
    • do not take more than 6 doses in 24 hours
     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
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  • Other information

    • each tablet contains: Calcium 10 mg/ tablet
    • store at 15o - 30o C (59o- 86o F)
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  • Inactive ingredients

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

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  • Questions or comments?

    Call toll free 1-877-753-3935

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  • Principal Display Panel

    Compare to maximum strength sudafed PE® sinus &allergy active ingredients*

    *This product is not manufactured or distributed by McNeil consumer healthcare, Division of McNeil-PPC, Inc. owner of the registered trademark Sudafed PE® Sinus and allergy

    Maximum Strength Sinus & Allergy

    For relief of: sinus pressure, sinus & nasal congestion, sneezing, itchy, watery eyes.

    Chlorpheniramine Maleate 4 mg

    Phenylephrine HCl 10 mg

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT

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  • Product Label

     Sunmark maximum strength sinus and allergy tablets

    Sinus and allergy tablets

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  • INGREDIENTS AND APPEARANCE
    SINUS AND ALLERGY 
    chlorpheniramine maleate, phenylephrine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-985
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    MINERAL OIL  
    STARCH, CORN  
    SODIUM STARCH GLYCOLATE TYPE A CORN  
    STEARIC ACID  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 7mm
    Flavor Imprint Code T127
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49348-985-04 1 in 1 CARTON
    1 24 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 12/07/2011
    Labeler - Mckesson (Sunmark) (177667227)
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