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  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 10 ML (1 UNIT DOSE)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. NDC INFORMATION -
    13. PRINCIPAL DISPLAY PANEL

Diphenhydramine Hcl Oral Solution Product Label

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

Other



Drug Facts


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 You Have



• a breathing problem such as chronic bronchitis
• glaucoma
• trouble urinating due to enlarged prostate gland


Otc - Ask Doctor/Pharmacist



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 traquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• 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



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

agedose
Adults and children over 12 years of age10 mL (25 mg) to 20 mL (50 mg)
Children 6 to under 12 years of age10 mL (25 mg)
Children under 6 years of ageDo not use


Other Information



• each 10 mL contains sodium: 6 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


Ndc Information -



25 mg/10 mL

Each 10 mL of Diphenhydramine HCl Oral Solution contains Diphenhydramine HCl 25 mg and is supplied in the following oral dosage forms:

NDC 57237-318-01: 10 mL unit dose cup

NDC 57237-318-11: 100 x 10 mL Unit-Dose Cups


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