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Sleepinal

Blairex Laboratories, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine hydrochloride 50 mg

Purpose

night-time sleep-aid

Use

for relief of occasional sleeplessness.

Warnings

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

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

When using this product avoid alcoholic drinks.

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.

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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

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

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

MAXIMUM STRENGTH

Sleepinal®

Night-time Sleep-Aid CAPSULES

NDC 50486-616-16

Non-habit Forming

One Capsule Dosage

Wake Up Refreshed

16 Capsules

Diphenhydramine Hydrochloride

Sleepinal

diphenhydramine hydrochloride CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50486-616
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 50 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
talc
MAGNESIUM STEARATE
GELATIN
FD&C BLUE NO. 1
FD&C RED NO. 3

Product Characteristics

Color Size Imprint Code Shape
BLUE (transparent) 19 mm SLEEPINAL; CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 8 in 1 BLISTER PACK
3 NDC:50486-616-16 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 1999-10-01


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Be sure to consult your doctor before taking any medication!
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