1. Home
  2. Labeler Index
  3. Johnson & Johnson Consumer Inc.
  4. 50580-341
  5. Label Information: Childrens Benadryl Allergy Plus Congestion

FDA Label for Childrens Benadryl Allergy Plus Congestion

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - ASK DOCTOR/PHARMACIST
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    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

Childrens Benadryl Allergy Plus Congestion Product Label

The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer 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.

Other



Drug Facts


Otc - Purpose



Active ingredients (in each 5 mL)Purposes
Diphenhydramine HCl 12.5 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

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
    • nasal congestion
    • stuffy nose
    • temporarily relieves these symptoms due to the common cold:
      • runny nose
      • sneezing
      • nasal congestion
      • stuffy nose
      • temporarily relieves sinus congestion and pressure

Do Not Use



  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have



  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

Otc - Ask Doctor/Pharmacist



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


When Using This Product



  • do not exceed recommended dose
  • 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

Stop Use And Ask A Doctor If



  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever

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



  • find right dose on chart below
  • mL = milliliter
  • take every 4 hours
  • do not take more than 6 doses in 24 hours
    • Age (yr)Dose (mL)
    children under 4 yearsdo not use
    children 4 to 5 yearsdo not use unless directed by a doctor
    children 6 to 11 years5 mL
    adults and children 12 years and over10 mL

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.


Other Information



  • each 5 mL contains: sodium 10 mg
  • store between 20-25°C (68-77°F). Protect from light.
    Store in outer carton until contents are used.
  • do not use if bottle wrap or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing

Inactive Ingredients



anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose


Questions Or Comments?



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


Principal Display Panel



NDC 50580-341-01

Children's
Benadryl®

ALLERGY PLUS
CONGESTION

Diphenhydramine HCl / antihistamine
Phenylephrine HCl / nasal decongestant
oral solution

4 Hours/Dose

RELIEF OF:

  • ✓Runny Nose
  • ✓Sneezing
  • ✓Itchy, Watery Eyes
  • ✓Itchy Throat or Nose
  • ✓Sinus Congestion
  • ✓Stuffy Nose

    • Alcohol Free
    Sugar Free

    ALLERGY + CONGESTION RELIEF

    Grape!
    Flavored Liquid

    4 fl oz (118 mL)

    PRINCIPAL DISPLAY PANEL - childrens 01

    PRINCIPAL DISPLAY PANEL - childrens 01


* Please review the disclaimer below.