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Diphenhydramine HCl Oral Solution 12.5 mg/5 mL


SPL UNCLASSIFIED SECTION

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


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


OTC - ASK DOCTOR/PHARMACIST SECTION

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 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

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


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