ADWE dye-free childrens allergy
Diphenhydramine hydrochloride · Syrup · Oral
Active ingredient
Active ingredient (in each 5 mL) Diphenhydramine HCl USP 12.5 mg
Purpose
Purpose Antihistamine
Uses
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
Warnings
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 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 Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Do not use
Do not use ▪ to make a child sleepy ▪ with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use
Ask a doctor before use if the child has ▪ a breathing problem such as chronic bronchitis ▪ glaucoma
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
When using this product
When using this product ▪ marked drowsiness may occur ▪ sedatives and tranquilizers may increase drowsiness ▪ excitability may occur, especially in children
Keep out of reach of children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
Directions
• find right dose on chart below
• take every 4 to 6 hours, or as directed by a doctor
• do not take more than 6 doses in 24 hours
• mL = milliliter Age (yr) Dose (mL) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL to 10 mL Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
Other information
Other information
• each 5 mL contains : sodium 3 mg
• store at room temperature)
• protect from sunlight
• see bottom panel for lot number and expiration date
• contains low sodium
Inactive ingredients
Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.
Label text from the FDA structured product label by RARITAN PHARMACEUTICALS INC (revised Jul 17, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Diphenhydramine Hydrochloride in 1 product
ADWE dye-free childrens allergy NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 68163-710 | Diphenhydramine Hydrochloride 12.5 mg/5mL Syrup | RARITAN PHARMACEUTICALS INC | OTC MONOGRAPH DRUG |
Frequently asked questions
What is ADWE dye-free childrens allergy used for?
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
Who makes ADWE dye-free childrens allergy?
ADWE dye-free childrens allergy is listed by 1 labeler in the FDA NDC directory, including RARITAN PHARMACEUTICALS INC.