FDA Label for Diphenhydramine Hcl Oral Solution
View Indications, Usage & Precautions
Diphenhydramine Hcl Oral Solution Product Label
The following document was submitted to the FDA by the labeler of this product Major� Pharmaceuticals. 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.
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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
age | dose |
---|---|
Children under 2 years of age | Do not use |
Children 2 to under 6 years of age | Do not use unless directed by a doctor |
Children 6 to under 12 years of age | 5 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
age | dose |
---|---|
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
Principal Display Panel
MAJOR®
NDC 0904-7323-41
Each 5 mL Contains:
Diphenhydramine HCL Oral Solution
12.5 mg/5 mL
Antihistamine
Delivers 5 mL • See insert
For Institutional Use Only
Cherry Flavor
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Sugar Free • Alcohol Free
MAJOR®
NDC 0904-7324-66
Each 10 mL Contains:
Diphenhydramine HCL Oral Solution
25 mg/10 mL
Antihistamine
Delivers 10 mL • See insert
For Institutional Use Only
Cherry Flavor
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Sugar Free • Alcohol Free
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