Label: DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet 

  • Label RSS
  • NDC Code(s): 76457-002-00
  • Packager: Simpex Pharma Pvt. Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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

  • Active ingredient (in each tablet)

    Diphenhydramine hydrochloride 25 mg

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  • Purpose

    Antihistamine

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  • Uses

    Temporarily relieves symptoms due to common cold, hay fever or other allergies affecting the upper respiratory tract

    • runny nose
    • sneezing
    • Ichy watery eyes
    • Iching of the nose or throat.
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  • Warnings

    Keep outer carton for complete warning and product information.

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  • Do not use

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

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  • Consult a doctor

    if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    if you are taking sedatives or tranquilizers
    • sedative, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability my occur especially in children.
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  • Pregnancy or breast feeding

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

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  • Keep out of reach of children.

    In case of overdose, get medical help or contact a poison control center right away. 1-800-222-1222.

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  • When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
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  • Directions

    • take every 4 to 6 hours
    • do not take more than 6 does in 24 hours
    • Adult and children 12 years of age and over - 1 to 2 tablet
    • Children 6 to 12 years of age - 1 tablet
    • Children 6 years of age - do not use this product in children under 6 years
    • Children under 4 years of age - do not use
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  • Other Information

    • each tablet contains: Calcium 25 mg/tablet
    • store at room temperature 15 to 30 degrees Celsius (59 degrees to 86 degrees Fahrenheit)
    • protect from light and moisture
    • do not use if imprented safety seal under cap is broken or missing.
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  • Inactive ingredient

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, opadry AMB white*, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, and titanium dioxide. *contains one or more of these ingredients.

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  • Questions or comments?

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  • Package Label

    Antihistamine 100 tablets

    Diphenhydramine hydrochloride

    Anti-Allergy Tablets

    • Temporarily relieves symptoms due to common cold hay fever or other allergies affecting the upper respiratory tract.
    • Runny nose
    • Sneezing
    • Ichy watery eyes
    • Iching of the nose or throat
    SIMPEX

    Manufactured by:
    SIMPEX PHARMA PVT. LTD.
    C-7 to C-13 and C-59 to C-64, Siggadi Growth Center
    (SIDCUL), Siggadi, Kotdwar-246149,
    District Pauri Garhwal, Uttrakhand, India
    Distributed by:
    Lot. No. :
    Mfg.Date:
    Exp.Date:

    carton

    bottle

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  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76457-002
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX  
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYSORBATE 80  
    POLYVINYL ALCOHOL  
    WATER  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color white (white) Score no score
    Shape ROUND (round) Size 8mm
    Flavor Imprint Code ;
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76457-002-00 1 in 1 CARTON
    1 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 11/15/2012
    Labeler - Simpex Pharma Pvt. Ltd (916758275)
    Registrant - Simpex Pharma Pvt. Ltd (916758275)
    Establishment
    Name Address ID/FEI Business Operations
    Simpex Pharma Pvt. Ltd 916758275 manufacture(76457-002)
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