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Generic: diphenhydramine hydrochloride is used for the treatment of Anxiety Disorders Infant, Newborn Infant, Premature Sleep Initiation and Maintenance Disorders Lactation Motion Sickness Nausea Rhinitis, Allergic, Perennial Sneezing Status Asthmaticus Urticaria


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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

OTC - ASK DOCTOR/PHARMACIST SECTION


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

OTC - WHEN USING SECTION


When using this product avoid alcoholic drinks.

OTC - STOP USE SECTION


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 SECTION


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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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

Otc - Questions Section


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

Package Label.principal Display Panel


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

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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