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Diphenhydramine HCl Oral Solution 12.5 mg/5 mL Diphenhydramine HCl Oral Solution 25 mg/10 mL


SPL UNCLASSIFIED SECTION

Drug Facts


Active ingredient per 5 mL (1 Unit Dose)

Diphenhydramine HCl 12.5 mg


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 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 istaking 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 

For the 5 mL Unit-Dose: 

• 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)

Directions

For the 10 mL Unit-Dose:

• take every 4 to 6 hours, or as directed by a physician • do not take more than 6 doses in 24 hours

Children under 6 years of age                   Do not use
Children 6 to under 12 years of age               10 mL (25 mg)
Adults and children 12 years of age and over 10 mL (25 mg) to 20 mL (50 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? (855) 879-4368


Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268

(800) 616-2471