Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 57a130db-2b27-4e09-b0bb-179d4ef52c15
Route
ORAL
Published
Effective Date 2024-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Citric Acid Monohydrate Agave Tequilana Juice Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-02
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:
    • runny nose 
    • sneezing
    • 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 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


Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Product Label
KINDERMED Kids Allergy Organic Cherry Flavor
Other Information
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • protect from light. Store in outer carton until contents are used
Inactive Ingredient

Organic agave syrup, non-GMO citric acid, organic natural flavor, purified water

Questions Or Comments?

Call 424-235-0355

Principal Display Panel

KIDS' Ages 6-11 yrs

ALLERGY

Diphenhydramine HCl

12.5 mg per 5 mL Oral Solution

Antihistamine

Organic Cherry Flavor

FL OZ (mL)

DOSAGE CUP PROVIDED

TAMPER EVIDENT: BOTTLE IS SAFETY SEALED WITH A PERFORATED BAND AROUND BOTTLE. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: KinderFarms®

Redondo Beach, CA 90277 USA

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
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 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


Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Product Label
KINDERMED Kids Allergy Organic Cherry Flavor
Other Information (Other information)
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • protect from light. Store in outer carton until contents are used
Inactive Ingredient (Inactive ingredient)

Organic agave syrup, non-GMO citric acid, organic natural flavor, purified water

Questions Or Comments? (Questions or comments?)

Call 424-235-0355

Principal Display Panel

KIDS' Ages 6-11 yrs

ALLERGY

Diphenhydramine HCl

12.5 mg per 5 mL Oral Solution

Antihistamine

Organic Cherry Flavor

FL OZ (mL)

DOSAGE CUP PROVIDED

TAMPER EVIDENT: BOTTLE IS SAFETY SEALED WITH A PERFORATED BAND AROUND BOTTLE. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: KinderFarms®

Redondo Beach, CA 90277 USA

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
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: 2026-02-15T12:03:40.833710 · Updated: 2026-03-14T23:03:51.620726