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  5. Label Information: Diphenhydramine Hcl

FDA Label for Diphenhydramine Hcl

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 5 ML)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Diphenhydramine Hcl Product Label

The following document was submitted to the FDA by the labeler of this product Pai Holdings, 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.

Other



Drug Facts


Active Ingredient (In Each 5 Ml)



Diphenhydramine HCl 12.5 mg


Purpose



Antihistamine


Uses



  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat

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 The Child Has



  • a breathing problem such as chronic bronchitis
  • glaucoma

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers


When Using This Product



  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

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



  • find right dose on chart below
  • mL = milliliter
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
    • Age (yr)Dose (mL)
    children under 2 yearsdo not use
    children 2 to 5 yearsdo not use unless directed by a doctor
    children 6 to 11 years5 mL to 10 mL

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.


Other Information



  • each 5 mL contains: sodium 10 mg
  • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.

Inactive Ingredients



citric acid anhydrous, glycerin, flavoring, purified water, saccharin sodium, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sorbitol.


Questions Or Comments?



Call 1-800-845-8210


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