drug facts

drug facts
SPL v8
SPL
SPL Set ID 8559be55-8b00-4353-8e26-b5dff2ada806
Route
oral
Published
Effective Date 2025-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (12.5 mg)
Inactive Ingredients
anhydrous citric acid glycerin poloxamer 407 water sodium benzoate sodium chloride trisodium citrate dihydrate sucrose d&c red no. 33 fd&c red no. 40

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2015-03-31

Purpose

Antihistamine

Description

Diphenhydramine HCl 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
  • 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 (yrs) 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


Other Information
  • each 5 mL contains: sodium 6 mg
  • store between 20-25ºC (68-77F). Do not refrigerate.
  • Protect from light.
Inactive Ingredients

citric acid, D&C red #33, FD&C red #40 flavors, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Description

Diphenhydramine HCl 12.5 mg

Principal Display Panel

Compare to the active ingredient Children's Benadryl® Allergy*

Children's

allergy relief

Oral Solution

Diphenhydramine HCl 12.5 mg 

antihistamine

relieves:

  • sneezing
  • running nose
  • itchy, watery eyes
  • itching of the nose or throat

for ages 6 to 11

alcohol free

cherry flavor

FL OZ (mL)

*This product is not manufactured or distributed b McNeil Consumer Healthcare, distributor of Benadryl® Allergy

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Manufactured by:

PL Developmnets

11865 S. Alameda St

Lynwood, CA 90262

Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Package Label
Children's Allergy Relief Diphenhydramine HCl 12.5 mg Cherry Flavor
Children's Allergy Relief Diphenhydramine HCl 12.5 mg Cherry Flavor
Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • 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:
    • runny nose
    • sneezing
    • 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 (yrs) 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


Other Information (Other information)
  • each 5 mL contains: sodium 6 mg
  • store between 20-25ºC (68-77F). Do not refrigerate.
  • Protect from light.
Inactive Ingredients (Inactive ingredients)

citric acid, D&C red #33, FD&C red #40 flavors, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Principal Display Panel

Compare to the active ingredient Children's Benadryl® Allergy*

Children's

allergy relief

Oral Solution

Diphenhydramine HCl 12.5 mg 

antihistamine

relieves:

  • sneezing
  • running nose
  • itchy, watery eyes
  • itching of the nose or throat

for ages 6 to 11

alcohol free

cherry flavor

FL OZ (mL)

*This product is not manufactured or distributed b McNeil Consumer Healthcare, distributor of Benadryl® Allergy

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Manufactured by:

PL Developmnets

11865 S. Alameda St

Lynwood, CA 90262

Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Package Label
Children's Allergy Relief Diphenhydramine HCl 12.5 mg Cherry Flavor
Children's Allergy Relief Diphenhydramine HCl 12.5 mg Cherry Flavor
Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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)
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • 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

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