Drug Facts
9a384e6f-f5b4-4daf-b268-d2d853eca002
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Diphenhydramine HCl 12.5 mg
Purpose
Antihistamine
Medication Information
Purpose
Antihistamine
Description
Diphenhydramine HCl 12.5 mg
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- runny nose
- itchy, watery eyes
- itching of the nose or throat
Directions
- do not take more than 6 doses in 24 hours
- take every 4 to 6 hours, or as directed by a doctor
- measure only with dosing cup provided. Do not use any other dosing device.
- mL = milliliter
- keep dosing cup with product
- find the right dose on the chart below
| age (yr) | dose (mL) |
| children 6 to 11 years | 5 mL to 10 mL |
| children 2 to 5 years | do not use unless directed by a doctor |
| children under 2 years | do not use |
Do Not Use
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
Packaging Label
Other Information
- each 5 mL contains: sodium 8 mg
- store between 20-25ºC (68-77ºF). Do not refrigerate
- Protect from light. Store in outer carton until contents are used.
Inactive Ingredients
carboxymethylcellulose sodium, citric acid, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
*Compare to the active ingredient in Children's Benadryl® Allergy
For Ages 6-11 Years
Children's Allergy Relief
Diphenhydramine HCI 125 mg/5 mL
Antihistamine Oral Solution
Bubble Gum Flavor
Dye-Free
Alcohol-Free
Relieves:
- Sneezing
- Runny nose
- Itchy, watery eyes
- Itching of the nose or throat
Dosing Cup included
FL OZ (mL)
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
Manufactured for FSA Store Inc.
240 W. 37th St., 6th Floor
New York, NY 10018
When Using This Product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
Active Ingredient (in Each 5 Ml)
Diphenhydramine HCl 12.5 mg
Keep Out of the Reach of Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Ask A Doctor Before Use If the Child Has
- a breathing problem such as chronic bronchitis
- glaucoma
- a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If the Child Is
taking sedatives or tranquilizers.
Structured Label Content
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- runny nose
- itchy, watery eyes
- itching of the nose or throat
Purpose
Antihistamine
Directions
- do not take more than 6 doses in 24 hours
- take every 4 to 6 hours, or as directed by a doctor
- measure only with dosing cup provided. Do not use any other dosing device.
- mL = milliliter
- keep dosing cup with product
- find the right dose on the chart below
| age (yr) | dose (mL) |
| children 6 to 11 years | 5 mL to 10 mL |
| children 2 to 5 years | do not use unless directed by a doctor |
| children under 2 years | do not use |
Do Not Use (Do not use)
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
Packaging Label
Other Information (Other information)
- each 5 mL contains: sodium 8 mg
- store between 20-25ºC (68-77ºF). Do not refrigerate
- Protect from light. Store in outer carton until contents are used.
Inactive Ingredients (Inactive ingredients)
carboxymethylcellulose sodium, citric acid, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol
Questions Or Comments? (Questions or comments?)
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
*Compare to the active ingredient in Children's Benadryl® Allergy
For Ages 6-11 Years
Children's Allergy Relief
Diphenhydramine HCI 125 mg/5 mL
Antihistamine Oral Solution
Bubble Gum Flavor
Dye-Free
Alcohol-Free
Relieves:
- Sneezing
- Runny nose
- Itchy, watery eyes
- Itching of the nose or throat
Dosing Cup included
FL OZ (mL)
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
Manufactured for FSA Store Inc.
240 W. 37th St., 6th Floor
New York, NY 10018
When Using This Product (When using this product)
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))
Diphenhydramine HCl 12.5 mg
Keep Out of the Reach of Children. (Keep out of the reach of children.)
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
- a breathing problem such as chronic bronchitis
- glaucoma
- a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)
taking sedatives or tranquilizers.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:54.900242 · Updated: 2026-03-14T23:02:43.906306