Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID bfcedca7-f758-4654-822a-5c431906f34d
Route
ORAL
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-30
Description

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine/ Cough suppressant

Medication Information

Purpose

Antihistamine/ Cough suppressant

Description

Diphenhydramine HCl 12.5 mg

Uses

temporarily relieves:

  • sneezing
  • runny nose
  • itchy nose or throat
  • itchy, watery eyes due to hay fever or other upper respiratory allergies
  • the impulse to cough
  • cough to help you get to sleep
  • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritant
  • the intensity of coughing
Purposes

Antihistamine/

Cough suppressant

Directions
  • adults and children 6 years and over: do not exceed more than 6 doses in any 24-hours unless directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • shake well before using
  • mL= milliliter
Age

 Dose
adults and children 12 years of age and over

 10 mL every 4 hours
children 6 to under 12 years of age

  5 mL every 4 hours
children 4 to under 6 years of age

 do not use unless directed by a doctor
children under 4 years of age 

 do not use



Do Not Use
  • in a child under 4 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • for the purpose of making your child sleepy
Questions?
Call 424-235-0355
Package Label
KINDERMED Kids Nighttime Cold & Cough Organic Cherry Flavor
Other Information
  • store between  20-25º (68-77ºF).
  • Do not refrigerate
  • protect from light
Inactive Ingredients

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

Principal Display Panel

KIDS' Ages 6 yrs+.

NIGHTTIME

COLD & COUGH

Diphenhydramine HCl 12.5 mg per 5 mL

Antihistamine/Cough Suppressant

Organic Cherry Flavor

DOSING CUP INCLUDED

FL OZ (mL)

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
  • do not exceed recommended dosage

  • marked drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If
  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
If Pregnant Or Breat Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredients (in Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the Chld Has
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • diabetes
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If the Child Is

taking sedatives or tranquilizers

Structured Label Content

Uses

temporarily relieves:

  • sneezing
  • runny nose
  • itchy nose or throat
  • itchy, watery eyes due to hay fever or other upper respiratory allergies
  • the impulse to cough
  • cough to help you get to sleep
  • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritant
  • the intensity of coughing
Purposes

Antihistamine/

Cough suppressant

Directions
  • adults and children 6 years and over: do not exceed more than 6 doses in any 24-hours unless directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • shake well before using
  • mL= milliliter
Age

 Dose
adults and children 12 years of age and over

 10 mL every 4 hours
children 6 to under 12 years of age

  5 mL every 4 hours
children 4 to under 6 years of age

 do not use unless directed by a doctor
children under 4 years of age 

 do not use



Do Not Use (Do not use)
  • in a child under 4 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • for the purpose of making your child sleepy
Questions? (QUESTIONS?)
Call 424-235-0355
Package Label
KINDERMED Kids Nighttime Cold & Cough Organic Cherry Flavor
Other Information (Other information)
  • store between  20-25º (68-77ºF).
  • Do not refrigerate
  • protect from light
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

KIDS' Ages 6 yrs+.

NIGHTTIME

COLD & COUGH

Diphenhydramine HCl 12.5 mg per 5 mL

Antihistamine/Cough Suppressant

Organic Cherry Flavor

DOSING CUP INCLUDED

FL OZ (mL)

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)
  • do not exceed recommended dosage

  • marked drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
If Pregnant Or Breat Feeding, (If pregnant or breat-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredients (in Each 5 Ml) (Active ingredients (in each 5 mL))

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the Chld Has (Ask a doctor before use if the chld has)
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • diabetes
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
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: 2026-02-15T12:03:39.315126 · Updated: 2026-03-14T23:03:50.462651