Label: LODRANE D- brompheniramine maleate and pseudoephedrine hydrochloride capsule 

  • 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 01/12

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  • Active ingredient

    Each green and white, LODRANE D capsule contains:

    Brompheniramine maleate ............... 4 mg
    Pseudoephedrine hydrochloride .... 60 mg

    In an immediate release formulation.

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  • Purpose

    • Antihistamine
    • Nasal Decongestant
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  • Uses

    LODRANE D capsules are indicated for the temporary relief of symptoms associated with allergic rhinitis, including runny nose, sneezing, itching of the nose or throat, itchy watery eyes, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies. Promotes nasal and/or sinus drainage.

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  • Warnings

    Do not exceed recommended dosage. Do not use if you have had an allergic reaction to any of the ingredients in this product. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. 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. May cause excitability especially in children. Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis. May cause drowsiness. Alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use Caution when driving a motor vehicle or operating machinery. Do not give this product to children under 12 years except under the advice and supervision of a physician. If pregnant or breast feeding ask a healthcare professional before use.

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  • KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, CONTACT A POISON CONTROL CENTER IMMEDIATELY.
  • Directions

    LODRANE D Capsules: Adults and children over 12 years of age: One capsule every 4 to 6 hours, not to exceed 4 capsules in 24 hours.

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  • Inactive ingredients

    Lactose monohydrate, magnesium stearate, silicon dioxide, and starch.

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  • How Supplied

    LODRANE D Capsules: Bottles of 60 Capsules (NDC 00095-0860-06). Each green and white capsule is imprinted “0860”.

    Manufactured for:
    ECR Pharmaceuticals
    Richmond, Virginia 23255

    MI 0860
    Rev. 01/2012
    OE1280

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  • Package/Label Principal Display Panel - Bottle Label

    NDC 00095-0860-06

    60 Capsules

    LODRANE® D Capsules

    EACH CAPSULE CONTAINS:

    Brompheniramine maleate ............... 4 mg
    Pseudoephedrine hydrochloride .... 60 mg
    In an immediate release formulation.

    USUAL DOSAGE: Adults and Children Over 12:
    1 Capsule every 4-6 hours.
    Do not exceed 4 capsules in 24 hours.

    For additional information, see accompanying product literature.

    KEEP THIS AND ALL MEDICATIONS
    OUT OF THE REACH OF CHILDREN.

    Store at room temperature.

    Manufactured for:
    ECR Pharmaceuticals
    Richmond, Virginia 23255

    ML 0860 LE2127 Rev. 06/2011

    Principal Display Panel - Bottle Label
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  • INGREDIENTS AND APPEARANCE
    LODRANE D 
    brompheniramine maleate and pseudoephedrine hydrochloride capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0095-0860
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE 4 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    SILICON DIOXIDE  
    STARCH, CORN  
    Product Characteristics
    Color GREEN, WHITE Score no score
    Shape OVAL Size 18mm
    Flavor Imprint Code 0860
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0095-0860-06 60 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/21/2011
    Labeler - ECR Pharmaceuticals (831116350)
    Establishment
    Name Address ID/FEI Business Operations
    Elite Laboratories Inc 785398728 MANUFACTURE(0095-0860)
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