Active ingredient per 5 mL (1 Unit Dose)
Diphenhydramine HCl 12.5 mg
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
Warnings
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
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
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
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
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
Rising Pharma Holdings, Inc.
