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  5. Label Information: Diphenhydramine Hydrochloride

FDA Label for Diphenhydramine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN.
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS OR COMMENTS
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Advance Pharmaceutical Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



(in each TABLET)

Diphenhydramine HCl 50 mg


Purpose



Sleep Aid


Uses



 relieves occasional sleeplessness


Warnings



Do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • 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

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives & 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



  • adults and children 12 years and over: take 1 tablet at bedtime
  • children under 12 years: ask a doctor

Other Information



  • store at 15-30 °C (59-86 °F)
  • protect from moisture

Inactive Ingredients



Croscarmellose sodium, dicalcium phosphate, FD&C blue# 1(Al-lake), Magnesium stearate, microcrystalline cellulose.


Questions Or Comments



TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

Manufactured by: Advance Pharmaceutical Inc. Holtsville, NY 11742

Call 631-981-4600, 8:30 am to 4:30 pm ET, Monday-Friday


Package Label.Principal Display Panel



DIPHENHYDRAMINE HYDROCHLORIDE Tablet, USP 50 MG

ANTIHISTAMINE

NDC: 17714-023-50 – 50 COUNT


* Please review the disclaimer below.