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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 Softgel)


Diphenhydramine HCl 50 mg

Purpose


Nighttime sleep-aid

Use

  • for relief of occasional sleeplessness

Warnings


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 bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION


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

OTC - WHEN USING SECTION


When using this product avoid alcoholic drinks

OTC - STOP USE SECTION


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

OTC - PREGNANCY OR BREAST FEEDING SECTION


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 of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Other Information

  • Store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
  • do not use if imprinted safety seal under cap is broken or missing 

Inactive Ingredients


FD&C blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol, titanium dioxide

Questions Or Comments?


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Principal Display Panel


MAXIMUM STRENGTH Nighttime Sleep-Aid

200 SOFTGELS

*Compare to the active ingredient in Unisom® SleepGels® Nighttime Sleep-Aid



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"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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