Children's Allergy - 505

Children's Allergy - 505
SPL v3
SPL
SPL Set ID fd04fb94-f581-4ca2-b7ac-20359093863e
Route
ORAL
Published
Effective Date 2023-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Citric Acid Monohydrate D&c Red No. 33 Fd&c Red No. 40 Glycerin Poloxamer 407 Water Sodium Benzoate Sodium Chloride Sodium Citrate Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-09-11

Description

Diphenhydramine HCL 12.5 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCL 12.5 mg

Uses

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

    •    sneezing

    •    itching of the nose or throat

    •    runny nose

    •    itchy watery eyes

•    temporarily relieves these symptoms due to the common cold:

    •    sneezing

    •    runny nose

Warnings

Do not use

•    with any other product containing diphenhydramine, even one used on skin

•    to make a child sleepy

Directions

•    if needed, take every 4-6 hours

•    do not take more than 6 doses in 24 hours



Children under 4 years of age:                                    do not use

Children 4 to under 6 years of age:                             do not use unless directed by a doctor

Children 6 to under 12 years of age:                           1 to 2 teaspoonfuls

                                                                               (12.5 mg to 25 mg)

Product Label

“MORE FOR YOUR DOLLAR”

MARKET BASKET ®

*COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ALLERGY LIQUID

Children’s Allergy

Diphenhydramine HCL Oral Solution Antihistamine

Relieves: 

•    Sneezing

•    Runny Nose

•    Itchy Watery Eyes

•    Itchy Throat

Alcohol-free

Cherry Flavor

4 FL OZ (118 mL)

Lot:

Exp:

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

*This product is not manufactured or distributed by McNeil-PPC, Inc. distributer of Benadryl® Allergy Liquid.

DISTRIBUTED BY

DEMOULAS SUPERMARKETS INC.

875 EAST STREET

TEWKSBURY MA 01876

BX-014 Rev 01

res

Other Information

•    Keep carton for full directions for use

•    each teaspoonful contains: sodium 10 mg

•    store at 20-25 ° C (68-77 ° F)

•    dosage cup provided

Inactive Ingredients



Citric acid, D and C Red # 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions Or Comments?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

When Using This Product

•    marked drowsiness may occur

•    excitability may occur, especially in children

•    sedatives and tranquilizers may increase drowsiness

Drug Factsactive Ingredient

Diphenhydramine HCL 12.5 mg

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 right away.

Ask A Doctor Before Use Ask A Doctor Or Pharmacist Before Use

Ask a doctor before use if the child has

•    glaucoma

•    a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before if the child is

taking sedatives or tranquilizers


Structured Label Content

Uses

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

    •    sneezing

    •    itching of the nose or throat

    •    runny nose

    •    itchy watery eyes

•    temporarily relieves these symptoms due to the common cold:

    •    sneezing

    •    runny nose

Purpose

Antihistamine

Warnings

Do not use

•    with any other product containing diphenhydramine, even one used on skin

•    to make a child sleepy

Directions

•    if needed, take every 4-6 hours

•    do not take more than 6 doses in 24 hours



Children under 4 years of age:                                    do not use

Children 4 to under 6 years of age:                             do not use unless directed by a doctor

Children 6 to under 12 years of age:                           1 to 2 teaspoonfuls

                                                                               (12.5 mg to 25 mg)

Product Label

“MORE FOR YOUR DOLLAR”

MARKET BASKET ®

*COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ALLERGY LIQUID

Children’s Allergy

Diphenhydramine HCL Oral Solution Antihistamine

Relieves: 

•    Sneezing

•    Runny Nose

•    Itchy Watery Eyes

•    Itchy Throat

Alcohol-free

Cherry Flavor

4 FL OZ (118 mL)

Lot:

Exp:

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

*This product is not manufactured or distributed by McNeil-PPC, Inc. distributer of Benadryl® Allergy Liquid.

DISTRIBUTED BY

DEMOULAS SUPERMARKETS INC.

875 EAST STREET

TEWKSBURY MA 01876

BX-014 Rev 01

res

Other Information

•    Keep carton for full directions for use

•    each teaspoonful contains: sodium 10 mg

•    store at 20-25 ° C (68-77 ° F)

•    dosage cup provided

Inactive Ingredients (Inactive ingredients)



Citric acid, D and C Red # 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions Or Comments? (Questions or comments?)

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

When Using This Product (When using this product)

•    marked drowsiness may occur

•    excitability may occur, especially in children

•    sedatives and tranquilizers may increase drowsiness

Drug Factsactive Ingredient (Drug FactsActive ingredient)

Diphenhydramine HCL 12.5 mg

Keep Out of Reach of 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 right away.

Ask A Doctor Before Use Ask A Doctor Or Pharmacist Before Use (Ask a doctor before use Ask a doctor or pharmacist before use)

Ask a doctor before use if the child has

•    glaucoma

•    a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before if the child is

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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