Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 40904eb3-723c-4ddc-8a0e-5ae5ef74c259

Route

ORAL

Published

Effective Date 2024-04-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Diphenhydramine (6.25 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

Agave Tequilana Juice Citric Acid Monohydrate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-04-29

Description

Diphenhydramine HCl 6.25 mg Phenylephrine HCl 2.5 mg

Purpose

Antihistamine/ Cough suppressant Nasal decongestant

Medication Information

Purpose

Antihistamine/ Cough suppressant Nasal decongestant

Description

Diphenhydramine HCl 6.25 mg Phenylephrine HCl 2.5 mg

Uses

temporarily relieves:

sneezing
runny nose
itchy nose or throat
itchy, watery eyes due to hay fever
nasal and sinus congestion
cough due to minor throat and bronchial irritation as may occur with a cold

Purposes

Antihistamine/

Cough suppressant

Nasal decongestant

Directions

do not give 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
mL= milliliter
shake well before using

age	dose
children 6 to under12 years of age	10 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
in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug contains an MAOI, ask a doctor or pharmacist before giving this product.
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 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 flavors, purified water

Principal Display Panel

KIDS NIGHTTIME COLD & COUGH Age 6-11 yrs

Diphenhydramine HCl 6.25 mg per 5 mL

Antihistamine/ Cough Suppressant

Phenylephrine HCl 2.5 mg per 5 mL

Nasal Decongestant

Organic Cherry Flavor

NO COMMON ALLERGENS.

NO DYES OR PARABENS.

DOSING CUP INCLUDED

FL OZ (mL)

TAMPER EVIDENT: BOTTLE IS SAFETY SEALED. 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

kinderfarms.com

When Using This Product

do not exceed recommended dosage
marked drowsiness may occur
excitability may occur, especially in children
sedatives and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If

nervousness, dizziness or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever
cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.

These could be signs of a serious condition.

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 6.25 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Chld Has

heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
cough that occurs with too much phlegm (mucus)
chronic cough that lasts, or as occurs with asthma
a breathing problem such as chronic bronchitis

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
nasal and sinus congestion
cough due to minor throat and bronchial irritation as may occur with a cold

Purposes

Antihistamine/

Cough suppressant

Nasal decongestant

Directions

do not give 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
mL= milliliter
shake well before using

age	dose
children 6 to under12 years of age	10 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
in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug contains an MAOI, ask a doctor or pharmacist before giving this product.
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 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 flavors, purified water

Principal Display Panel

KIDS NIGHTTIME COLD & COUGH Age 6-11 yrs

Diphenhydramine HCl 6.25 mg per 5 mL

Antihistamine/ Cough Suppressant

Phenylephrine HCl 2.5 mg per 5 mL

Nasal Decongestant

Organic Cherry Flavor

NO COMMON ALLERGENS.

NO DYES OR PARABENS.

DOSING CUP INCLUDED

FL OZ (mL)

TAMPER EVIDENT: BOTTLE IS SAFETY SEALED. 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

kinderfarms.com

When Using This Product (When using this product)

do not exceed recommended dosage
marked drowsiness may occur
excitability may occur, especially in children
sedatives and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever
cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.

These could be signs of a serious condition.

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 6.25 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Chld Has (Ask a doctor before use if the chld has)

heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
cough that occurs with too much phlegm (mucus)
chronic cough that lasts, or as occurs with asthma
a breathing problem such as chronic bronchitis

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

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "6.25", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "AGAVE TEQUILANA JUICE", "unii": "GVG8G0207O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves: sneezing runny nose itchy nose or throat itchy, watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold", "Purposes": "Antihistamine/ Cough suppressant Nasal decongestant", "Directions": "do not give 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 mL= milliliter shake well before using age dose children 6 to under12 years of age 10 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 in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug contains an MAOI, ask a doctor or pharmacist before giving this product. 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 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 flavors, purified water", "Principal Display Panel": "KIDS NIGHTTIME COLD & COUGH Age 6-11 yrs Diphenhydramine HCl 6.25 mg per 5 mL Antihistamine/ Cough Suppressant Phenylephrine HCl 2.5 mg per 5 mL Nasal Decongestant Organic Cherry Flavor NO COMMON ALLERGENS. NO DYES OR PARABENS. DOSING CUP INCLUDED FL OZ (mL) TAMPER EVIDENT: BOTTLE IS SAFETY SEALED. 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 kinderfarms.com", "When using this product": "do not exceed recommended dosage marked drowsiness may occur excitability may occur, especially in children sedatives and tranquilizers may increase drowsiness", "Stop use and ask a doctor if": "nervousness, dizziness or sleeplessness occur symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition.", "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 6.25 mg Phenylephrine HCl 2.5 mg", "Ask a doctor before use if the chld has": "heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) chronic cough that lasts, or as occurs with asthma a breathing problem such as chronic bronchitis", "Ask a doctor or pharmacist before use if the child is": "taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:56.984618 · Updated: 2026-03-14T23:02:46.668637