Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Anhydrous Citric Acid Glycerin Water Sodium Benzoate Trisodium Citrate Dihydrate Carboxymethylcellulose Sodium Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-02-29

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

sneezing
runny nose
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 (yr)	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

Package Label

QUALITY CHOICE Dye-Free Children's Allergy

Other Information

each 5 mL contains: sodium 8 mg
store between 20-25°C (68-77°F). Do not refrigerate.
Protect from light. Store in outer carton until contents are used.

Inactive Ingredients

anhydrous citric acid, carboxymethycellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol

Questions Or Comments?

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in Children's Benadryl® Allergy

Dye-Free

Children's

Allergy

Antihistamine

Diphenhydramine Hydrochloride 12.5mg / 5 mL Oral Solution

Liquid Medication

Relieves

Runny Nose | Sneezing |

Itchy, Watery Eyes | Itchy Throat

For Ages 6 to 11 Years

Alcohol-Free

Dye-Free

Bubble Gum Flavored

FL OZ (mL)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A., Inc,©

43157 W.Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

When Using This Product

marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in 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 Ingredient (in Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the Child Has

a breathing problem such as chronic bronchitis
glaucoma
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:

sneezing
runny nose
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 (yr)	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

Package Label

QUALITY CHOICE Dye-Free Children's Allergy

Other Information (Other information)

each 5 mL contains: sodium 8 mg
store between 20-25°C (68-77°F). Do not refrigerate.
Protect from light. Store in outer carton until contents are used.

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethycellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol

Questions Or Comments? (Questions or comments?)

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in Children's Benadryl® Allergy

Dye-Free

Children's

Allergy

Antihistamine

Diphenhydramine Hydrochloride 12.5mg / 5 mL Oral Solution

Liquid Medication

Relieves

Runny Nose | Sneezing |

Itchy, Watery Eyes | Itchy Throat

For Ages 6 to 11 Years

Alcohol-Free

Dye-Free

Bubble Gum Flavored

FL OZ (mL)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

43157 W.Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

When Using This Product (When using this product)

marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children

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 Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Diphenhydramine HCl 12.5 mg

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
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

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose 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 (yr) 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", "Package Label": "QUALITY CHOICE Dye-Free Children's Allergy", "Other information": "each 5 mL contains : sodium 8 mg store between 20-25°C (68-77°F). Do not refrigerate. Protect from light. Store in outer carton until contents are used.", "Inactive ingredients": "anhydrous citric acid, carboxymethycellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol", "Questions or comments?": " Call 1-248-449-9300 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "*Compare to the active ingredient in Children's Benadryl® Allergy Dye-Free Children's Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg / 5 mL Oral Solution Liquid Medication Relieves Runny Nose | Sneezing | Itchy, Watery Eyes | Itchy Throat For Ages 6 to 11 Years Alcohol-Free Dye-Free Bubble Gum Flavored FL OZ (mL) *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Benadryl® Allergy. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING . Distributed by C.D.M.A., Inc,© 43157 W.Nine Mile Novi, MI 48376-0995 www.qualitychoice.com", "When using this product": "marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in 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 ingredient (in each 5 mL)": "Diphenhydramine HCl 12.5 mg", "Ask a doctor before use if the child has": "a breathing problem such as chronic bronchitis glaucoma 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