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 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 5 Ml (1 Unit Dose)
Diphenhydramine HCl 12.5 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 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 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
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) |
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
Ndc Information -
12.5 mg/5 mL
Each 5 mL of Diphenhydramine HCl Oral Solution contains Diphenhydramine HCl 12.5 mg and is supplied in the following oral dosage forms:
NDC 57237-317-05: 5 mL unit dose cup
NDC 57237-317-51: 100 x 5 mL Unit-Dose Cups
Principal Display Panel
12.5 mg/5 mL
Case Label NDC 57237-317-51
Lid Label NDC 57237-317-05* Please review the disclaimer below.