FDA Label for Diphenhydramine Hcl 25 Mg

View Indications, Usage & Precautions

ACTIVE INGREDIENT (IN EACH CAPSULE)
PURPOSE
USES
WARNINGS
OTC - ASK DOCTOR
OTC - ASK DOCTOR/PHARMACIST
OTC - WHEN USING
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
OTHER
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine Hcl 25 Mg Product Label

The following document was submitted to the FDA by the labeler of this product Reliable 1 Laboratories Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Capsule)

Diphenhydramine HCL 25 mg

Purpose

Antihistamine

Uses

temporarily releaves these symptoms of hay fever or other upper respiratory allergies:

runny nose
itchy nose or throat
sneezing
itchy, watery eyes

Warnings

Do not use

with any otherprodcut containing diphenhydramine, even one use on skin
to make a child sleepy

Otc - Ask Doctor

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharamcist before use if you are taking sedatives or tranquilizers

Drug Facts continued of back of label

Otc - When Using

When using this product

you may get very drowsy
avoid alcoholic drinks
alcohol, sedatives, & tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - 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.

Directions

take every 4-6 hours
do not take more than 6 doses in 24 hours

adults and children 12 years and over	1 to 2 capsules
children 6 to under 12 years	1 capsule
children under 6 years	do not use

Other Information

store at room temperature
protect from moisture

Inactive Ingredients

benzl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methlyparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

Questions Or Comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

Other

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS BROKEN OR MISSING

Distributed by: Reliable 1 Laboratories LLC

Valley Stream, NY 11580

www.reliable1labs.com

Drug Facts

Package Label.Principal Display Panel

NDC 69618-024-01