Label: NOBLEAID ALLERGY RELIEF- diphenhydramine hydrochloride tablet

  • NDC Code(s): 81533-300-10, 81533-300-24
  • Packager: Noble OTC LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 1, 2024

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

  • Drug Facts

  • Active Ingredients (in each caplet)

    Diphenhydramine HCl 25mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: itchy or watery eyes
       • runny nose itchy nose or throat
       • sneezing

    temporarily relieves these symptoms of the common cold:
       • sneezing
       • runny nose

  • Warnings

    Do not Use:

    With any product containing diphenhydramine, even one used on skin
    To make a child sleepy

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are
    taking sedative or tranquilizers

    When using this product
    marked drowsiness may occur
    avoid alcoholic drinks
    excitability may occur especially in children
    alcohol, sedatives and tranquilizers may increase drowsiness
    be careful when driving a motor vehicle or operating machine

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

  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental 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

    • take every 4 to 6 hours, or as directed by the doctor
    •  24 hours
    • adults and children under 12 yrs old and over 1 to 2 caplets children 6 to 12 years of age 1 caplet under children 6 years of age

  • Other information

    Each caplet contains: Calcium 23.52 mg
    Store at controlled room temperature 20-25°C (68-77°F)
    Read all the product information before using
    TAMPER EVIDENT Do not use if safety seal under cap is broken or missing

  • Inactive ingredients

    Colloidal silicon dioxide, Croscarmellose sodium, Stearic acid, Talc, Dicalcium phosphate, Polyethylene glycol, Magnesium stearate, Phloxine B Lake, Microcrystalline cellulose, Polyvinyl alcohol, Titanium dioxide

  • Questions or Comments?

    Please call (347)378-8990 Monday through Friday 9-5 or by Email Info@nobleotc.com

  • SPL UNCLASSIFIED SECTION

    Experience fast relief from itchy, puffy, red or watery eyes typically caused by pet dander, hair, pollen, dust and hay fever. You don't have to suffer through allergy symptoms another day longer. Itchy eyes can negatively affect your vision, focus and even work performance.

    Diphenhydramine HCL helps reduce and relieve congestion of your nose, sinus and throat to help you breathe better and deeper. The antihistamine effects of this over the counter medication can help reduce the symptoms of the common cold like a runny nose, coughing or sneezing.

    Allergy symptoms can make your whole day miserable, but they can also affect your sleep. The antihistamine response may naturally cause drowsiness in both adults and kids, so it is often taken in the evening or before bed to help you fall asleep faster and stay asleep

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy.

    Manufactured for
    Noble OTC LLC
    788 Convery Blvd,
    Perth Amboy NJ 08861
    www.nobleotc.com

  • Packaging

    pink-allergy relief

  • INGREDIENTS AND APPEARANCE
    NOBLEAID ALLERGY RELIEF 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81533-300
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code D25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81533-300-2424 in 1 BLISTER PACK; Type 0: Not a Combination Product07/01/2023
    2NDC:81533-300-10100 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/01/2023
    Labeler - Noble OTC LLC (041836435)