FDA Label for Sleepinal

View Indications, Usage & Precautions

ACTIVE INGREDIENT (IN EACH CAPSULE)
PURPOSE
USE
DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE
OTC - ASK DOCTOR/PHARMACIST
OTC - WHEN USING
OTC - STOP USE
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
ADULTS AND CHILDREN 12 YEARS AND OVER:
OTHER INFORMATION
INACTIVE INGREDIENTS
OTC - QUESTIONS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sleepinal Product Label

The following document was submitted to the FDA by the labeler of this product Blairex Laboratories, 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.

Active Ingredient (In Each Capsule)

Diphenhydramine hydrochloride 50 mg

Purpose

night-time sleep-aid

Use

for relief of occasional sleeplessness.

Do Not Use

in 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 bronchitis
glaucoma
trouble urinating due to the enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

When using this product avoid alcoholic drinks.

Otc - Stop Use

Stop use and ask doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

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.

Adults And Children 12 Years And Over:

take 1 capsule at bedtime if needed, or as directed by a doctor.

Other Information

store at 15-30°C (59-86°F)
protect from excessive moisture
protect from light
retain product in box until administered

Inactive Ingredients

FD&C blue no. 1, FD&C red no. 3, gelatin, lactose, magnesium stearate, talc

Manufactured for:

Blairex Laboratories, Inc.
P.O. Box 2127 Columbus, IN 47202 USA

Otc - Questions

Questions or Comments? Call TOLL FREE 1-800-252-4739
www.sleepinal.net

Package Label.Principal Display Panel

MAXIMUM STRENGTH

Sleepinal^®

Night-time Sleep-Aid CAPSULES

NDC 50486-616-32

Non-habit Forming

One Capsule Dosage

Wake Up Refreshed

32 Capsules

Diphenhydramine Hydrochloride

PACKAGE NOT CHILD RESISTANT