7eb709a5-c587-4f1d-bc2d-576d07a3a3bf
7eb709a5-c587-4f1d-bc2d-576d07a3a3bf
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Antihistamine
Description
Diphenhydramine HCl, 12.5 mg
Medication Information
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 you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to the enlarged prostate gland
Ask a doctor or pharmacist before use if you are takingsedatives or tranquilizers
When using this product:
- excitability might occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness effect
- be careful when driving a motor vehicle or operating machinery
If pregnant of breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Uses
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
Purpose
Antihistamine
Directions
- Take every 4 to 6 hours, or as directed by a doctor.
- Do not exceed recommended dose.
| Adults and Children 12 years of age and over | take 10 to 20 mL (2 to 4 tsp) not to exceed 300 mg in 24 hours |
|
Children 6 to under 12 years of age Children under 6 years of age: |
take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours consult a doctor |
Other Information
- Store at controlled room temperature 15º - 30ºC (59º - 86ºF).
- Do not refrigerate. Avoid excessive heat or humidity.
- Protect from light.
Inactive Ingredients
Citric acid, FD&C red #40, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, strawberry flavor, sucralose.
Description
Diphenhydramine HCl, 12.5 mg
Section 42229-5
TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS TORN, BROKEN OR MISSING.
Section 50565-1
Product Label
Active Ingredient (in Each 5ml Tsp)
Diphenhydramine HCl, 12.5 mg
Questions Or Comments? 1 888 462 4166
Structured Label Content
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 you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to the enlarged prostate gland
Ask a doctor or pharmacist before use if you are takingsedatives or tranquilizers
When using this product:
- excitability might occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness effect
- be careful when driving a motor vehicle or operating machinery
If pregnant of breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Uses
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
Purpose
Antihistamine
Directions
- Take every 4 to 6 hours, or as directed by a doctor.
- Do not exceed recommended dose.
| Adults and Children 12 years of age and over | take 10 to 20 mL (2 to 4 tsp) not to exceed 300 mg in 24 hours |
|
Children 6 to under 12 years of age Children under 6 years of age: |
take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours consult a doctor |
Other Information
- Store at controlled room temperature 15º - 30ºC (59º - 86ºF).
- Do not refrigerate. Avoid excessive heat or humidity.
- Protect from light.
Inactive Ingredients
Citric acid, FD&C red #40, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, strawberry flavor, sucralose.
Section 42229-5 (42229-5)
TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS TORN, BROKEN OR MISSING.
Section 50565-1 (50565-1)
Product Label (Product label)
Active Ingredient (in Each 5ml Tsp) (Active Ingredient (in each 5mL tsp))
Diphenhydramine HCl, 12.5 mg
Questions Or Comments? 1 888 462 4166 (Questions or Comments? 1-888-462-4166)
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:06:16.951386 · Updated: 2026-03-14T23:08:57.795400