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Generic: diphenhydramine hcl 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 soft gel)

Diphenhydramine HCL 50 mg

Otc - Purpose Section


Purpose

Nighttime sleep-aid

Indications & Usage Section


USES

Use for relief of occasional sleeplessness.

Warnings Section


Warnings

Do not use
  • for children under 12 years of age
  • with any other products 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.

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

avoid alcoholic drinks

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.

Otc - Keep Out Of Reach Of Children Section


KEEP OUT OF THE REACH OF CHILDREN.

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

Dosage & Administration Section


Directions

adults and children 12 years of age and over: Take 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Storage And Handling Section


Other information
  • store at room temperature 15º to 30º C (59º to 86º F)
  • avoid excessive heat
  • do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredient Section


Inactive Ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink

Otc - Questions Section


Questions or comments?
  • Call 1-855-642-2594


*Compare to active ingredient in Unisom ® SleepGels ®

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom ®

Rev.: 03/2023

Manufactured by:

Apnar Pharma LLP

East Windsor, NJ 08520

Package Label.principal Display Panel


NDC 24689-154-01

SleepAid

Diphenhydramine HCL 50 mg
  • Safe, non habit-forming
  • One softgel per dose

Made in USA

100 Soft gels



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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."

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"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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