42ad618b-d2e5-4c58-9407-386df4fe4004
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
(in each 5 mL teaspoonful) Diphenhydramine HCl 12.5mg
Purpose
Antihistamine
Medication Information
Purpose
Antihistamine
Description
(in each 5 mL teaspoonful) Diphenhydramine HCl 12.5mg
Uses
- temporarily relieves these symptoms due to hay fever or other respiratory allergies:
- sneezing
- itching of the nose or throat
- runny nose
- itchy watery eyes
- temporarily relieves these symptoms due to the common cold:
- sneezing
- runny nose
Section 50565-1
Warnings
Do not use
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
Ask a doctor before use if the child has
- glaucoma
- a breathing problem such as chronic bronchitis
Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers
When using this product
- marked drowsiness may occur
- excitability may occur, especially in children
- sedatives and tranquilizers may increase drowsiness
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- if needed, take every 4-6 hours
- do not take more than 6 doses in 24 hours
| Children under 4 years of age: | do not use |
| Children 4 to under 6 years of age: | do not use unless directed by a doctor |
| Children 6 to under 12 years of age: | 1 to 2 teaspoonfuls (12.5 mg to 25 mg) |
Product Label
Active Ingredient
(in each 5 mL teaspoonful)
Diphenhydramine HCl 12.5mg
Other Information
- Keep carton for full directions for use
- each teaspoonful contains: sodium 10 mg
- store at 20° - 25° C (68° - 77° F)
- dosage cup provided
Inactive Ingredients
Citric acid, D&C Red # 33, FD&C Red # 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose
Questions Or Comments?
Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
Structured Label Content
Uses
- temporarily relieves these symptoms due to hay fever or other respiratory allergies:
- sneezing
- itching of the nose or throat
- runny nose
- itchy watery eyes
- temporarily relieves these symptoms due to the common cold:
- sneezing
- runny nose
Section 50565-1 (50565-1)
Purpose
Antihistamine
Warnings
Do not use
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
Ask a doctor before use if the child has
- glaucoma
- a breathing problem such as chronic bronchitis
Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers
When using this product
- marked drowsiness may occur
- excitability may occur, especially in children
- sedatives and tranquilizers may increase drowsiness
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- if needed, take every 4-6 hours
- do not take more than 6 doses in 24 hours
| Children under 4 years of age: | do not use |
| Children 4 to under 6 years of age: | do not use unless directed by a doctor |
| Children 6 to under 12 years of age: | 1 to 2 teaspoonfuls (12.5 mg to 25 mg) |
Product Label (Product label)
Active Ingredient
(in each 5 mL teaspoonful)
Diphenhydramine HCl 12.5mg
Other Information
- Keep carton for full directions for use
- each teaspoonful contains: sodium 10 mg
- store at 20° - 25° C (68° - 77° F)
- dosage cup provided
Inactive Ingredients (Inactive ingredients)
Citric acid, D&C Red # 33, FD&C Red # 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose
Questions Or Comments? (Questions or comments?)
Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:03:06.168732 · Updated: 2026-03-14T23:02:57.214195