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

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 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

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

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

Questions Or Comments?

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

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

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

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

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

Questions Or Comments? (Questions or comments?)

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

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

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

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Raw Label Data

All Sections (JSON)

{"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", "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", "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", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "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", "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."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information