Pharbedryl Capsule
FDA Label NDC 16103-348

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharbest Pharmaceuticals, Inc. for the product Pharbedryl (NDC 16103-348). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(in each banded capsule), purpose, uses:, do not use, ask a doctor or pharmacist before use, ask a doctor or pharmacist before use of you are, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(In Each Banded Capsule)

Diphenhydramine HCL 25 mg

Purpose

Antihistamine

Uses:

  • Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies:
    •                     -Sneezing
                        -Nasal congestion
                        -Runny nose
                        -Itchy, watery eyes

Do Not Use

  • With any other product containing diphenhydramine, even one used on skin.

Ask A Doctor Or Pharmacist Before Use

If you have
  • Trouble urinating due to an enlarged prostate gland
  • A breathing problem such as emphysema or chronic bronchitis
  • Glaucoma

Ask A Doctor Or Pharmacist Before Use Of You Are

Taking sedatives or tranquilizers

When Using This Product

  • Avoid alcoholic drinks
  • Marked drowsiness may occur
  • Excitability may occur, especially in children
  • Alcohol, sedatives and tranquilizers may increase drowsiness
  • Be careful when driving a motor vehicle or operating machinery

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions:

  • Take every 4-6 hours
  • Do not exceed 6 doses in 24 hours.
    • Adults and children 12 years of age or over
    		25 mg to 50 mg
    (1 to 2 capsules)                                    
    Children 6 to under 12 years of age
    		12.5 mg** to 25 mg (1 capsule)
    Children under 6 years
    		ask a doctor
    **12.5 mg dosage strength is not available in this package.
    Do not attempt to break capsule.

Other Information:

  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • Store at controlled room temperature 15°-30°C (59°-86°F) 
  • Protect from moisture
  • Use by expiration date on package

Questions? Adverse Drug Event Call: (866)562-2756

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