db5a5eff-1bb1-4d00-8c01-caae7a1c7223
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Diphenhydramine HCl USP 12.5 mg
Purpose
Antihistamine
Medication Information
Purpose
Antihistamine
Description
Diphenhydramine HCl USP 12.5 mg
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
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
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.
Questions Or Comments?
1-866-467-2748
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.
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
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
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.
Questions Or Comments? (Questions or comments?)
1-866-467-2748
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.
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