Zonalon label

Zonalon

Zonalon Recall

Get an alert when a recall is issued.

Side Effects & Adverse Reactions

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
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

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful 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. 

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

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.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

  • 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
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

History

There is currently no drug history available for this drug.

Other Information

There are no additional details available for this product.

Zonalon Manufacturers

  • Prestium Pharma, Inc.
    Zonalon | Woonsocket Prescription Center,incorporated
    No Recall

    Zonalon | Woonsocket Prescription Center,incorporated

    Zonalon | Woonsocket Prescription Center,incorporated
    take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours  adults and children 12
     years and over   1 to 2 tablets   children 6 to under 12
     years   1 tablet   children under 6 years   do not use
  • Pharmaderm A Division Of Fougera Pharmaceuticals Inc.
    Zonalon | Pharmaderm A Division Of Fougera Pharmaceuticals Inc.
    No Recall

    Zonalon | Pharmaderm A Division Of Fougera Pharmaceuticals Inc.

    Zonalon | Pharmaderm A Division Of Fougera Pharmaceuticals Inc.

    A thin film of Zonalon® Cream should be applied four times each day with at least a 3 to 4 hour interval between applications. There are no data to establish the safety and effectiveness of Zonalon® Cream when used for greater than 8 days. Chronic use beyond eight days may result in higher systemic levels and should be avoided. Use of Zonalon® Cream for longer than 8 days may result in an increased likelihood of contact sensitization.

    The risk for sedation may increase with greater body surface area application of Zonalon® Cream (See WARNINGS section). Clinical experience has shown that drowsiness is significantly more common in patients applying Zonalon® Cream to over 10% of body surface area; therefore, patients with greater than 10% of body surface area (see WARNINGS section) affected should be particularly cautioned concerning possible drowsiness and other systemic adverse effects of doxepin. If excessive drowsiness occurs, it may be necessary to do one or more of the following: reduce the body surface area treated, reduce the number of applications per day, reduce the amount of cream applied, or discontinue the drug.

    Occlusive dressings may increase the absorption of most topical drugs; therefore, occlusive dressings should not be utilized with Zonalon® Cream.

  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Zonalon | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    No Recall

    Zonalon | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

    Zonalon | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

    A thin film of Zonalon® Cream should be applied four times each day with at least a 3 to 4 hour interval between applications. There are no data to establish the safety and effectiveness of Zonalon® Cream when used for greater than 8 days. Chronic use beyond eight days may result in higher systemic levels and should be avoided. Use of Zonalon® Cream for longer than 8 days may result in an increased likelihood of contact sensitization.

    The risk for sedation may increase with greater body surface area application of Zonalon® Cream (See WARNINGS section). Clinical experience has shown that drowsiness is significantly more common in patients applying Zonalon® Cream to over 10% of body surface area; therefore, patients with greater than 10% of body surface area (see WARNINGS section) affected should be particularly cautioned concerning possible drowsiness and other systemic adverse effects of doxepin. If excessive drowsiness occurs, it may be necessary to do one or more of the following: reduce the body surface area treated, reduce the number of applications per day, reduce the amount of cream applied, or discontinue the drug.

    Occlusive dressings may increase the absorption of most topical drugs; therefore, occlusive dressings should not be utilized with Zonalon® Cream.