FDA Label for Diphenhydramine Hcl

View Indications, Usage & Precautions

DRUG FACTS
OTC - PURPOSE
USES
DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
WHEN USING THIS PRODUCT
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREAST-FEEDING,
KEEP OUT OF REACH OF CHILDREN.
OVERDOSAGE
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENT
QUESTION OR COMMENTS?
OTHER
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine Hcl Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, Inc.. 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.

Drug Facts

Active Ingredient (in each mini-capsule)

Diphenhydramine HCl 25mg

Otc - Purpose

Purpose

Nighttime sleep-aid

Uses

for relief of occasional sleeplessness

Do Not Use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have

a breathing problem such as emphysema or chronic brochitis
glaucoma
difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

When Using This Product

avoid alcoholic beverages

Stop Use And Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

Overdosage

In case of overdose, get medical help or contact Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 12 years and over: take 2 mini-capsules (50mg) at bedtime if nedded, or as directed by a doctor

Other Information

Store at 25°C(77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number
protect from moisture

Inactive Ingredient

citric acid, edible ink, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, lactose, polysorbate 80, potassium sorbate, starch, titanium dioxide

Question Or Comments?

1-800-231-4670

Other

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF BLUE

BAND AROUND CAPSULE IS BROKEN OR MISSING

*This product is not manufactured or distributed by Chattem, Inc., owner of the trademarks Unisom® and SleepMinis™.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com® 1-800-SHOP CVS

V-34571

Package Label.Principal Display Panel

CVSHealth

Compare to the active ingredient in Unisom® SleepMinis™*

Nighttime Sleep-Aid

Diphenhydramine HCl, 25mg