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Drug Facts
Diphenhydramine Hcl Oral Solution
FDA Label NDC 57237-318
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Diphenhydramine Hcl Oral Solution (NDC 57237-318). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient per 10 ml (1 unit dose), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
| age | dose |
|---|---|
| Adults and children over 12 years of age | 10 mL (25 mg) to 20 mL (50 mg) |
| Children 6 to under 12 years of age | 10 mL (25 mg) |
| Children under 6 years of age | Do 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
Principal Display Panel
25 mg/10 mL
Case Label NDC 57237-318-11
Diphenhydramine-case-lab (Diphenhydramine Case Lab)
Lid Label NDC 57237-318-01
Diphenhydramine-lid-lab (Diphenhydramine Lid Lab)
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