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  5. Label Information: Benadryl

FDA Label for Benadryl

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Benadryl Product Label

The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. 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.

Other



Drug Facts


Active Ingredient (In Each Tablet)



Diphenhydramine HCl 25 mg


Purpose



Antihistamine


Uses



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

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



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

Otc - Ask Doctor/Pharmacist



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


When Using This Product



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

Otc - Pregnancy Or Breast Feeding



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


Otc - 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. (1-800-222-1222)


Directions



  • •take every 4 to 6 hours, or as directed by a doctor
  • •do not take more than 6 times in 24 hours

    • adults and children 12 years and over

    1 to 2 tablets

    children 6 to under 12 years

    1 tablet

    children under 6 years

    do not use


Other Information



  • •each tablet contains: calcium 15 mg
  • •store between 20-25°C (68-77°F). Protect from light.
  • •do not use if carton is opened or if blister unit is broken

Inactive Ingredients



carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide


Questions Or Comments?



call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)


Principal Display Panel



NDC 71205-521-06

Benadryl®

ALLERGY

Diphenhydramine HCl 25mg | Antihistamine

✓ Sneezing
✓ Runny Nose
✓ Itchy, Watery Eyes
✓ Itchy Throat

ULTRATABS®*
*small tablet size

actual size

6 TABLETS

71205-521-06 - benadryl 01

71205-521-06 - benadryl 01


* Please review the disclaimer below.