Chlorpheniramine Maleate
FDA Label NDC 61919-402

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Direct Rx for the product Chlorpheniramine Maleate (NDC 61919-402). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient section, otc - purpose section, indications & usage section, otc - keep out of reach of children section, dosage & administration section, information for patients section, inactive ingredient section, otc - questions section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient Section

Chlorpheniramine maleate 4 mg

Otc - Purpose Section

Antihistamine

Indications & Usage Section

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Otc - Keep Out Of Reach Of Children Section

    Do not use

    to make a child sleepy.

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis  
    • glaucoma
    • 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

      • drowsiness may occur
      • avoid alcoholic beverages
      • alcohol, sedatives, and tranquilizers may increase drowsiness
      • use caution when driving a motor vehicle or operating machinery
      • excitability may occur, especially in children

        • 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 (1-800-222-1222) right away.

Dosage & Administration Section

    adults and children
    12 years  of age
    and over    		1 tablet every 4 to 6
    hours. Do not take more than 6 tablets in 24 hours.
    children 6 to under 12 years of  age

    		1/2 tablet (break tablet in half) every 4 to 6 hours.
    Do not exceed 3 whole tablets in 24 hours.
    children under 6 years of agedo not use this product in children under 6 years of age

Information For Patients Section

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from excessive moisture
  • see end flap for expiration date and lot number

Inactive Ingredient Section

    corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose

Otc - Questions Section

(800) 616-2471

Warnings Section


Do not use

to make a child sleepy.

Ask a doctor before use if you have
a breathing problem such as emphysema or chronic bronchitis
glaucoma
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
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children

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 (1-800-222-1222) right away

Package Label.Principal Display Panel

Image Description (Chlorph)

Image Description (Chlorph)

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