Label: PHARBEDRYL- diphenhydramine hcl capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 11, 2021

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  • Active ingredient (in each capsule)

    Diphenhydramine HCl 50mg

    Purpose

    Antihistamine

  • Uses

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

    Do not use

    • to make child sleepy
    • with any other product containing diphenhydramine, even one used on skin 
  • Ask a doctor 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 if 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 & 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 overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take every 4-6 hours or as directed by a doctor
    • do not take more than 6 doses in 24 hours.

    Adults and children 12 years of age & over

    1 capsule

    Children under 12 years of age

    Ask a doctor

  • Other information

    Tamper Evident:
    • do not use if safety seal under the cap is broken or missing
    • store at room temperature (15°-30°C) 
    • protect from excessive moisture
  • Inactive ingredients

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

  • Questions?

    Adverse drug event call (866)562-2756 Mon - Fri 8 AM to 4 PM

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 16103-0347-08

    Manufactured in the USA

    PHARBEDRYL

    Diphenhydramine HCl 50mg

    Antihistamine

    • Sneezing • Runny Nose

    • Itchy, Watery Eyes • Itchy Throat

    1000 CAPSULES

    Pharbedryl 50mg capsule Product Label

  • INGREDIENTS AND APPEARANCE
    PHARBEDRYL 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-347
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code PH013
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16103-347-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/2006
    2NDC:16103-347-08100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/11/2006
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835analysis(16103-347) , manufacture(16103-347) , pack(16103-347) , label(16103-347)
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