Active Ingredient (In Each Capsule)
Diphenhydramine HCl 50 mg
Diphenhydramine Hydrochloride Capsule
FDA Label NDC 42806-649
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Epic Pharma, Llc for the product Diphenhydramine Hydrochloride (NDC 42806-649). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each capsule), purpose, uses, warnings, keep out of the reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy nose or throat
- itchy, watery eyes
Warnings
Do not use with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- you may get very drowsy
- 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
Ask a doctor or pharmacist before use if you are taking sedatives or tranqulizers
When using this product
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of The Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Venter right away.
Directions
- adults & children 12 years and over: take 1 capsule every 4-6 hours; not more than 6 does in 24 hours
- children under 12 years: ask a doctor
Other Information
- store at 15°-30°C (59°-86°F)
- protect from moisture
- This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP
Inactive Ingredients
benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate
Questions Or Comments?
call 888-374-279 1, 8:30 am - 4:30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFTEY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED
Distributed by:
Epic Pharma, LLC
Laurelton, NY
11413
Package Label - Principal Display Panel - 50 Mg
Diphenhydramine HCl Capsules, USP 50 mg
ANTIHISTAMINE
1000 Capsules
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
Diphenhydramine-50mg-1000s (Diphenhydramine 50mg 1000s) 
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