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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. QUESTIONS? ADVERSE DRUG EVENT CALL:
    13. HOW SUPPLIED

Diphenhydramine Hcl Product Label

The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. 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 haveTrouble urinating due to enlarged prostate glandA breathing problem such as emphysema or chronic bronchitisGlaucomaIf 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.


Directions:



Take every 4-6 hoursDo not take more than 6 doses in 24 hours.Adults and children 12 years or over1 capsule                                      Children under 12 years ask 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

Questions? Adverse Drug Event Call:



1-800-687-0176


How Supplied



Product: 50090-4539

NDC: 50090-4539-0 30 CAPSULE in a BOTTLE

NDC: 50090-4539-2 15 CAPSULE in a BOTTLE

NDC: 50090-4539-3 20 CAPSULE in a BOTTLE

NDC: 50090-4539-5 10 CAPSULE in a BOTTLE


* Please review the disclaimer below.