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  5. Label Information: Diphenhydramine Hcl

FDA Label for Diphenhydramine Hcl

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CAPSULE)
    2. PURPOSE
    3. USES:
    4. WARNINGS:
    5. DO NOT USE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE
    7. WHEN USING THIS PRODUCT
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS:
    11. OTHER INFORMATION:
    12. INACTIVE INGREDIENTS:
    13. QUESTIONS? ADVERSE DRUG EVENT CALL:
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine Hcl Product Label

The following document was submitted to the FDA by the labeler of this product Pd-rx Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Capsule)



Diphenhydramine HCL 50 mg


Purpose



Antihistamine


Uses:



Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies

  • sneezing
  • nasal congestion
  • runny nose
  • itchy, watery eyes

Warnings:




Do Not Use



  • With any other product containing Diphenhydramine HCL, including one applied topically.

Ask A Doctor Or Pharmacist Before Use



If you have

  • trouble urinating due to enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • if you are taking sedatives or tranquilizers

When Using This Product



  • avoid alcoholic drinks
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

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:



  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours.
    • Adults and children 12 years & over1 capsule                                     
    Children under 12 yearsask a doctor

    **25 mg strength is not available in this package. Do not attempt to break capsules.


Other Information:



  • Store at room temperature 15-30  degrees C (59-86 degrees F)
  • Protect from excessive moisture

Inactive Ingredients:



Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate


Questions? Adverse Drug Event Call:



1-800-687-0176


* Please review the disclaimer below.