Request Item

BENADRYL LIQUID BUBBLE GUM 12.5MG 4OZ

Generic: Diphenhydramine hydrochloride

NDC:50580-0535-01

Manufacturer:Kenvue Brands LLC

Strength:12.5 mg/5mL

Dosage Form:SOLUTION

Route:ORAL

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Drug Information

Identification

Generic Name

Diphenhydramine hydrochloride

Brand Name

Childrens Benadryl DYE-FREE ALLERGY

Labeler / Distributor

Kenvue Brands LLC

Product Type

HUMAN OTC DRUG

Administration

Dosage Form

SOLUTION

Route of Administration

ORAL

FDA Application Number

M012

Active Ingredients

Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg/5mL

Pharmacological Class

Histamine H1 Receptor Antagonists [MoA]Histamine-1 Receptor Antagonist

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Wholesale compliance resources

DSCSA T2 documents DSCSA compliance resource hub

Drug Resources

Diphenhydramine hydrochloride Drug Page NDC 50580-0535-01 Lookup

Clinical Drug Information

Indications & 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

Warnings

Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers 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 right away. (1-800-222-1222)

Dosage & Administration

Directions find right dose on chart below mL = milliliter take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours Age (yr) Dose (mL) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL to 10 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.