db5a5eff-1bb1-4d00-8c01-caae7a1c7223
db5a5eff-1bb1-4d00-8c01-caae7a1c7223
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Antihistamine
Description
Diphenhydramine HCl USP 12.5 mg
Medication Information
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
Purpose
Antihistamine
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
- 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
anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.
Description
Diphenhydramine HCl USP 12.5 mg
Principal Display Panel
NDC 51316-710-08
*Compare to theactive ingredient in Children's Benadryl® Dye-Free*
Dye-Free
Children’s Allergy Relief
Diphenhydramine HCl l Antihistamine
Oral Solution
For Relief Of:
- Runny nose
- sneezing
- itchy, watery eyes
- Itchy Throat or Nose
Sugar Free
Natural Cherry Flavor
8 FL. OZ. (236 mL)
Distributed by:
*This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Children’s Benadryl® Dye –Free.
Section 50565-1
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)
Section 50567-7
When using this product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
Section 50568-5
Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers
Section 50569-3
Ask a doctor before use if the child has
- a breathing problem such as chronic bronchitis
- glaucoma
Section 50570-1
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Questions Or Comments?
1-866-467-2748
Active Ingredient (in Each 5 Ml)
Diphenhydramine HCl USP 12.5 mg
Structured Label Content
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
Purpose
Antihistamine
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.
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
NDC 51316-710-08
*Compare to theactive ingredient in Children's Benadryl® Dye-Free*
Dye-Free
Children’s Allergy Relief
Diphenhydramine HCl l Antihistamine
Oral Solution
For Relief Of:
- Runny nose
- sneezing
- itchy, watery eyes
- Itchy Throat or Nose
Sugar Free
Natural Cherry Flavor
8 FL. OZ. (236 mL)
Distributed by:
*This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Children’s Benadryl® Dye –Free.
Section 50565-1 (50565-1)
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)
Section 50567-7 (50567-7)
When using this product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers
Section 50569-3 (50569-3)
Ask a doctor before use if the child has
- a breathing problem such as chronic bronchitis
- glaucoma
Section 50570-1 (50570-1)
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Questions Or Comments? (Questions or comments?)
1-866-467-2748
Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))
Diphenhydramine HCl USP 12.5 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:34.707230 · Updated: 2026-03-14T23:11:10.262850