Label: NARAMIN- diphenhydramine hydrochloride solution

  • 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 May 28, 2014

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  • NARAMIN Antihistamine Oral Solution

  • Active ingredient (per 5 ml = one pre-filled whistle)*

    Diphenhydramine HCl 12.5 mg

  • Purpose

    Antihistamine

  • Uses

    For the temporary relief of these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
  • Warnings

    Do not use

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • a sodium-restricted diet
    • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you

    are taking sedatives or tranquilizers

    When using this product

    marked drowsiness may occur

    avoid alcoholic beverages

    alcohol, sedatives, and tranquilizers may increase the drowsiness effect

    use caution when driving a motor vehicle or operating machinery

    excitability may occur, especially in children

    Choking Hazard: Small parts. Keep out of reach of 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    Adults and children 12 years of age and over

    Take 2-4 pre-filled whistles every 4 to 6 hours, not to exceed 24 whistles in 24 hours, or as directed by a doctor

    Children 6 to under 12 years of age

    Take 1-2 pre-filled whistles every 4 to 6 hours, not to exceed 12 whistles in 24 hours, or as directed by a doctor

    Children under 6 years of age

    Consult a doctor

  • Other information

    • Each pre-fille whistle contains 14 mg of sodium
    • Protect from light.
    • SAFETY SEALED: This product is protected by a sealed pouch. Do not use if individual foil pouch is torn or damaged.
    • Whistle is not child resistant. Do not remove whistle from child resistant foil pouch prior to use.
    • Store between 68 degrees-77 degrees F (20 degrees - 25 degrees C)
    • Store in outer carton until contents are used.
  • Inactive ingredients

    anhydrous citric acid, DandC red no. 33, FDandC red no.40, flavor, glycerin, monoammonium glycyrrhizinate, poloxamer 407, sodium benzoate, sodium chloride, sodium citrate, sucrose, water

  • Questions or comments?

    1-855-251-0106

  • NARAMIN Antihistamine Oral Solution 10-5ml whistles (58292-010-05)

    Outer Label

    Inner Label

  • INGREDIENTS AND APPEARANCE
    NARAMIN 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58292-010
    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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58292-010-0510 in 1 PACKAGE
    15 mL in 1 AMPULE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/28/2014
    Labeler - National Pharma Industries Inc (078725867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Plastikon Healthcare, LLC041717941manufacture(58292-010)
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