Diphenhydramine Hcl Oral Solution
FDA Label NDC 57237-317

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 57237-317). 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 5 ml (1 unit dose), purpose, uses, do not use, ask a doctor before use if the child has, 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

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

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)

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

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