Label: DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride 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 November 22, 2017

If you are a consumer or patient please visit this version.

View All Sections
  • 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 over1 to 2 capsules
    children 6 years to under 12 years of age1 capsule
    children under 6 years of agedo not use this product in children under 6 years of age

    50 MG

    adults and children 12 years of age and over1 capsule
    children 6 years to under 12 years of ageAsk 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

  • PRINCIPAL DISPLAY PANEL

    DRUG: Diphenhydramine Hydrochloride

    GENERIC: Diphenhydramine Hydrochloride

    DOSAGE: CAPSULE

    ADMINSTRATION: ORAL

    NDC: 70518-0861-0

    COLOR: pink

    SHAPE: CAPSULE

    SCORE: No score

    SIZE: 14 mm

    IMPRINT: cpc;836

    PACKAGING: 30 in 1 BOTTLE, PLASTIC

    ACTIVE INGREDIENT(S):

    • DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 1

    INACTIVE INGREDIENT(S):

    • D&C RED NO. 28
    • GELATIN
    • LACTOSE
    • FD&C BLUE NO. 1
    • FD&C RED NO. 40
    • STARCH, CORN

    Remedy_Label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE  
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0861(NDC:0904-2056)
    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
    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 (UNII: J2B2A4N98G)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorpink (pink, banded in red around the middle) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code cpc;836
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70518-0861-030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33611/22/2017
    Labeler - REMEDYREPACK INC. (829572556)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!