FDA Label for Benadryl Allergy

View Indications, Usage & Precautions

Benadryl Allergy Product Label

The following document was submitted to the FDA by the labeler of this product R J General Corporation. 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.

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

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

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. (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 over1 to 2 tablets
    children 6 to under 12 years1 tablet
    children under 6 yearsdo 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 pouch is torn or damaged

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)


Active ingredient made in Japan

Distributed by: JOHNSON & JOHNSON CONSUMER INC.

McNeil Consumer Healthcare Division

Fort Washington, PA 19034 USA

©J&JCI 2021

Repackaged & distributed by:

RJ General

2024 Northwest Drive

Cincinnati OH 45231


Principal Display Panel



Benadryl ®

ALLERGY ®

EFFECTIVE ALLERGY RELIEF WHEN YOU NEED IT! ®

Diphenhydramine HCl 25 mg | Antihistamine

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat
  • 30 PACKETS OF 2 TABLETS EACH


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