Children's Allergy

SPL v2

SPL

SPL Set ID e880b8d7-61c3-41cc-e053-2995a90aaaeb

Route

ORAL

Published

Effective Date 2023-12-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Agave Tequilana Juice Water Citrus Fruit

Identifiers & Packaging

Pill Appearance

Color: brown

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-04-26

Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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

Dosage and Administration

Directions

take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours
use only with enclosed dose cup. Do not use with any other dosing device.

adults and children 12 years of age and over	10 - 20 mL
children 6 to under 12 years	5 - 10 mL
children 2 to under 6 years	do not use unless directed by a doctor
children under 2 years	do not use

Description

Drug Facts

Section 42229-5

Drug Facts

Section 43683-2

Directions

take every 4 to 6 hours, or as directed by a doctor

do not take more than 6 doses in 24 hours

use only with enclosed dose cup. Do not use with any other dosing device.

adults and children 12 years of age and over	10 - 20 mL
children 6 to under 12 years	5 - 10 mL
children 2 to under 6 years	do not use unless directed by a doctor
children under 2 years	do not use

Section 44425-7

Other information

store between 20-25°C (68-77°F)

Section 50565-1

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

Section 50567-7

When using this product

marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Section 50569-3

Ask a doctor before use if you have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to enlargement of the prostate gland

Section 50570-1

Do not use

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Section 51727-6

Inactive ingredients

organic agave syrup, natural citric extract, purified water

Section 51945-4

Children's

Genexa®

MEDICINE MADE CLEAN

Ages 6+

Allergy

Diphenhydramine HCl Oral Solution

12.5 mg per 5 mL | Antihistamine

Sneezing

Itchy, Watery Eyes

Itchy Throat or Nose

Runny Nose

Compare to active ingredient in Children’s

Benadryl® Allergy Liquid Cherry*

How we're different

Made without:

FD&C red no. 40,

sodium benzoate, sucrose & more!

Organic Agave Syrup Flavor

Alcohol Free

4 FL OZ (118 mL) Dosing cup included

Section 53413-1

Questions?

1-855-436-3921

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions

take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours
use only with enclosed dose cup. Do not use with any other dosing device.

adults and children 12 years of age and over	10 - 20 mL
children 6 to under 12 years	5 - 10 mL
children 2 to under 6 years	do not use unless directed by a doctor
children under 2 years	do not use

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 43683-2 (43683-2)

Directions

take every 4 to 6 hours, or as directed by a doctor

do not take more than 6 doses in 24 hours

use only with enclosed dose cup. Do not use with any other dosing device.

adults and children 12 years of age and over	10 - 20 mL
children 6 to under 12 years	5 - 10 mL
children 2 to under 6 years	do not use unless directed by a doctor
children under 2 years	do not use

Section 44425-7 (44425-7)

Other information

store between 20-25°C (68-77°F)

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product

marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Section 50569-3 (50569-3)

Ask a doctor before use if you have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to enlargement of the prostate gland

Section 50570-1 (50570-1)

Do not use

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Section 51727-6 (51727-6)

Inactive ingredients

organic agave syrup, natural citric extract, purified water

Section 51945-4 (51945-4)

Children's

Genexa®

MEDICINE MADE CLEAN

Ages 6+

Allergy

Diphenhydramine HCl Oral Solution

12.5 mg per 5 mL | Antihistamine

Sneezing

Itchy, Watery Eyes

Itchy Throat or Nose

Runny Nose

Compare to active ingredient in Children’s

Benadryl® Allergy Liquid Cherry*

How we're different

Made without:

FD&C red no. 40,

sodium benzoate, sucrose & more!

Organic Agave Syrup Flavor

Alcohol Free

4 FL OZ (118 mL) Dosing cup included

Section 53413-1 (53413-1)

Questions?

1-855-436-3921

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Advanced Ingredient Data

[{"name": "AGAVE TEQUILANA JUICE", "unii": "GVG8G0207O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRUS FRUIT", "unii": "XDK00Z8012", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "Directions take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours use only with enclosed dose cup. Do not use with any other dosing device. adults and children 12 years of age and over 10 - 20 mL children 6 to under 12 years 5 - 10 mL children 2 to under 6 years do not use unless directed by a doctor children under 2 years do not use", "34071-1": "Warnings", "42229-5": "Drug Facts", "43683-2": "Directions take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours use only with enclosed dose cup. Do not use with any other dosing device. adults and children 12 years of age and over 10 - 20 mL children 6 to under 12 years 5 - 10 mL children 2 to under 6 years do not use unless directed by a doctor children under 2 years do not use", "44425-7": "Other information store between 20-25°C (68-77°F)", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)", "50567-7": "When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children", "50569-3": "Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to enlargement of the prostate gland", "50570-1": "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "51727-6": "Inactive ingredients organic agave syrup, natural citric extract, purified water", "51945-4": "Children's Genexa® MEDICINE MADE CLEAN Ages 6+ Allergy Diphenhydramine HCl Oral Solution 12.5 mg per 5 mL | Antihistamine Sneezing Itchy, Watery Eyes Itchy Throat or Nose Runny Nose Compare to active ingredient in Children’s Benadryl® Allergy Liquid Cherry* How we're different Made without: FD&C red no. 40, sodium benzoate, sucrose & more! Organic Agave Syrup Flavor Alcohol Free 4 FL OZ (118 mL) Dosing cup included", "53413-1": "Questions? 1-855-436-3921", "53414-9": "If pregnant or breastfeeding, ask a health professional before use.", "55105-1": "Purpose Antihistamine", "55106-9": "Active ingredient (in each 5 mL) Diphenhydramine HCl 12.5 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:38.246117 · Updated: 2026-03-14T23:07:45.169331