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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: CPC 835     SHAPE: capsule
    COLOR: pink

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Active Ingredient (in Each Banded Capsule)


Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Purpose


Antihistamine

Use


25 MG
  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itchy throat and nose
  • Temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

50 MG
  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold
    • sneezing
    • runny nose
    • itchy, watery eyes
    • itchy throat and nose

Warnings


Do not use

25 MG
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

50 MG
  • to make a child sleepy
  • with any other product containing diphenhydramine, including one applied topically

Ask A Doctor Before Use If You Have


25 MG
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

50 MG
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist


before use if you are taking sedatives or tranquilizers

When Using This Product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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

  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours

25 MG
adults and children 12 years of age and over 1 to 2 capsules
children 6 years to under 12 years of age 1 capsule
children under 6 years of age do not use this product in children under 6 years of age

50 MG
adults and children 12 years of age and over 1 capsule
children 6 years to under 12 years of age Ask a doctor, the proper dosage strength is not available in this package**

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Other Information

  • Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]
  • Protect from moisture
  • Contains lactose

Inactive Ingredients


D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

Questions?


Questions or comments? (800) 616-2471

Distributed By


MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

How Supplied


Product: 50090-3867

NDC: 50090-3867-1 28 CAPSULE in a BOTTLE

NDC: 50090-3867-0 30 CAPSULE in a BOTTLE

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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