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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. DO NOT USE
    5. ASK A DOCTOR OR PHARMACIST BEFORE USE
    6. WHEN USING THIS PRODUCT
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS:
    10. OTHER INFORMATION:
    11. INACTIVE INGREDIENTS:
    12. HOW SUPPLIED
    13. PRINCIPAL DISPLAY PANEL

Diphenhydramine Hcl Product Label

The following document was submitted to the FDA by the labeler of this product Physicians Total Care, 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 25 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.

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.

Directions:



  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours.
    • Adults and children 12 years or over
    		1 to 2 capsule                                     
    Children 6 to under 12 years
    		1 capsule
    Children under 6 years
    		ask a doctor


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

How Supplied



Diphenhydramine HCL 25 mg Capsules

Bottles of 10
NDC 54868-0026-5
Bottles of 20
NDC 54868-0026-6
Bottles of 30
NDC 54868-0026-1
Bottles of 60
NDC 54868-0026-7
Bottles of 90
NDC 54868-0026-8
Bottles of 100
NDC 54868-0026-0
Bottles of 1000
NDC 54868-0026-4


Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

Principal Display Panel



Diphenhydramine HCL Capsules

25 mg

image of label - 0026

image of label - 0026


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