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  5. Label Information: Diphenhydramine Hydrochloride

FDA Label for Diphenhydramine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH CAPLET)
    3. PURPOSES
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. IF PREGNANT OR BREAST-FEEDING,
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. IN CASE OF OVERDOSE,
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS?
    16. PRINCIPAL DISPLAY PANEL

Diphenhydramine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Bonita Pharmaceuticals Llc. 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.

Drug Facts




Active Ingredient (In Each Caplet)



Diphenhydramine HCl 25 mg


Purposes



Antihistamine


Uses



Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • itching of the nose and throat
  • sneezing

Do Not Use



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

Ask A Doctor Before Use If You Have



  • glaucoma
  • difficulty in urinating due to an enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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 effect
  • 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.


Otc - Keep Out Of Reach Of Children



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 to 6 hours as needed
  • do not take more than 6 times in 24 hours or as directed by a doctor

    • Adults and children 12 years and older

    • 1 or 2 caplets (25mg to 50mg)

      • Children under 12years

      • ask a doctor

Other Information



  • Store at room temperature
  • keep lid tightly closed in dry place
  • Do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients



Croscarmellose Sodium, D&C Red #27, Dicalcium Phosphate Dihydrate, Hydroxypropyle MethylCellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Propylene Glycol, Silica, Stearic Acid and Titanium Dioxide.


Questions?



If you have any questions or comments, or to report an adverse event, please contact (855) 729-7200.


* Please review the disclaimer below.