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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


IMPRINT: SL     SHAPE: oval
    COLOR: blue

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Drug Facts

Active Ingredient (in Each Caplet)


Diphenhydramine HCl 25 mg

Purpose


Nighttime 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 an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION


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

When using this product

  • avoid alcoholic drinks
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

  • sleeplessness persists 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children.

Overdose warning


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

Directions

adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years do not use

Other Information

  • each caplet contains: calcium 15 mg
  • store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • do not use if carton tape or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing

Inactive Ingredients


carnauba wax, croscarmellose sodium, dibasic calcium phosphate, FD&C Blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions Or Comments?


call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Principal Display Panel


FROM THE MAKERS OF TYLENOL ®PM

NDC 50580-843-12 Non-habit Forming

Simply Sleep ®

Diphenhydramine HCl Nighttime Sleep Aid Does NOT Contain Pain Reliever *Capsule-Shaped Tablets

Actual Size

100 Caplets*

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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