1. Home
  2. Labeler Index
  3. Everpharm Llc
  4. 84415-012
  5. Label Information: Diphenhydramine Hcl Oral Solution

FDA Label for Diphenhydramine Hcl Oral Solution

View Indications, Usage & Precautions

Table of Contents

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

Diphenhydramine Hcl Oral Solution Product Label

The following document was submitted to the FDA by the labeler of this product Everpharm 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 Per 5 Ml (1 Unit Dose)



Diphenhydramine HCl 12.5 mg


Active Ingredient Per 10 Ml (1 Unit Dose)



Diphenhydramine HCl 25 mg


Purpose



Antihistamine


Uses



Temporarily relieves these symptoms due to hay fever or other 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 istaking 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 accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)


Directions



For the 5 mL Unit-Dose: 

• take every 4 to 6 hours, or as directed by a physician

• do not take more than 6 doses in 24 hours

agedose
Children under 2 years of ageDo not use
Children 2 to under 6 years of ageDo not use unless directed by a doctor
Children 6 to under 12 years of age5 mL (12.5 mg) to 10 mL (25 mg)

For the 10 mL Unit-Dose:

• take every 4 to 6 hours, or as directed by a physician
• do not take more than 6 doses in 24 hours

agedose
Children under 6 years of age                   Do not use
Children 6 to under 12 years of age               10 mL (25 mg)
Adults and children 12 years of age and over 10 mL (25 mg) to 20 mL (50 mg) 


Other Information



• each 5 mL contains sodium: 3 mg
• store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
• do not use if lid is torn or broken


Inactive Ingredients



Inactive ingredients: citric acid, flavor, FD&C red#40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose


* Please review the disclaimer below.