FDA Label for Pharbedryl

View Indications, Usage & Precautions

Pharbedryl Product Label

The following document was submitted to the FDA by the labeler of this product Ulai Health Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Banded Capsule)



Diphenhydramine HCl 50mg


Purpose



Antihistamine


Uses



  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • temporarily relieves these symptoms due to common cold:
  • runny nose
  • sneezing

Do Not Use



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

Ask A Doctor Before Use If You Have



  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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



  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives & tranquilizers may increase drowsiness

  • use caution 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 (1-800-222-1222).


Directions



  • take every 4 to 6 hours, or as directed by a doctor
  • do not exceed 6 doses in 24 hours
  • adults and children 12 years and over

    1 capsule

    children under 12 years

    ask a doctor


Other Information



  • store at 20-25oC (68-77oF)

Inactive Ingredients



black iron oxide, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, sodium lauryl sulfate


Questions Or Comments?



(866) 562-2756 (Mon- Fri 8 AM to 4 PM EST)


Package Label.Principal Display Panel



PHARBEST

NDC 73057-347-11

Manufactured in the USA

PHARBEDRYL

Diphenhydramine HCl 50 mg

Antihistamine

•Sneezing                   •Runny Nose

•Itchy, Watery Eyes     •Itchy Throat

1000 CAPSULES


* Please review the disclaimer below.