Diphenhydramine HCl Oral Solution

Drug Facts

Diphenhydramine HCl 12.5 mg

Antihistamine

• 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

Label information

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

Label information

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)

• 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)

• 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

Inactive ingredients:  citric acid, flavor, FD&C red#40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Questions or comments? Call 1-844-474-7464

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

FG-35/Iss.: 10/2023

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

12.5 mg/5 mL

Case Label NDC 57237-317-51

[Image in the official label — see DailyMed source]

Lid Label NDC 57237-317-05

[Image in the official label — see DailyMed source]