Diphenhydramine HCl Oral Solution 25 mg/10 mL
SPL UNCLASSIFIED SECTION
Drug Facts
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
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 you have
• a breathing problem such as chronic bronchitis• glaucoma• trouble urinating due to enlarged prostate gland
OTC - ASK DOCTOR/PHARMACIST SECTION
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
If pregnant or breast-feeding, ask a healthcare professional before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
| 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
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-36/Iss.:10/2023
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