Label: ALLERGY RELIEF- diphenhydramine hcl liquid

  • NDC Code(s): 54859-811-16
  • Packager: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
  • 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 October 13, 2019

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

  • ACTIVE INGREDIENT

    Active ingredient (in each 5 mL teaspoonful)

    Diphenhydramine HCl 12.5 mg

  • PURPOSE

    Purpose

    Antihistamine

  • INDICATIONS & USAGE

    Uses

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

    Warnings

    Do not use

    • with any other product conatining diphenhydramine, including one used on the skin
    • to make a child sleepy

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

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

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not exceed recommended dose
    • take every 4 to 6 hours as needed, or as directed by a doctor
    • do not take more than 6 doses in 24 hours
    • adults and children 12 years and over: 10 to 20 mL (2 to 4 teaspoonful)
    • children under 12 years: consult a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients: Artificial and natural cherry flavor, citric acid, FD&C #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose and sucrose.

  • QUESTIONS

    Questions or comments? 1-800-540-3765

  • PRINCIPAL DISPLAY PANEL

    LiquidAllergy

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-811
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-811-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2019
    Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)
    Registrant - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)
    Establishment
    NameAddressID/FEIBusiness Operations
    LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION037342305manufacture(54859-811)