Childrens Benadryl-D ALLERGY and SINUS description, usages, side effects, indications, overdosage, supplying and lots more!

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Childrens Benadryl-D ALLERGY and SINUS

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Childrens Benadryl-D ALLERGY and SINUS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each 5 mL = 1 teaspoonful) Purpose
Diphenhydramine HCl 12.5 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant

Childrens Benadryl-D ALLERGY and SINUS 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

Warnings

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

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

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

  • find right dose on chart below
  • mL = milliliter; tsp = teaspoonful
  • take every 4 hours
  • do not take more than 6 doses in 24 hours
Age (yr) Dose (mL or tsp)
children under 4 years do not use
children 4 to 5 years do not use unless directed by a doctor
children 6 to 11 years 5 mL (1 tsp)
adults and children 12 years and over 10 mL (2 tsp)

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 (1 tsp) 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
  • see bottom panel for lot number and expiration date

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

PRINCIPAL DISPLAY PANEL

NDC 50580-781-04

children's
Benadryl-D
®

ALLERGY
& SINUS
Diphenhydramine HCl/antihistamine
Phenylephrine HCl/nasal decongestant
oral solution

Relieves

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

Diphenhydramine HCl

  • Sinus Congestion
  • Stuffy Nose

Phenylephrine HCl

Grape
FLAVORED LIQUID
Alcohol &
Sugar Free

THE HISTAMINE
BLOCKER
®

4 fl oz
(118 ml)

Childrens Benadryl-D ALLERGY and SINUS

Childrens Benadryl-D ALLERGY and SINUS

Diphenhydramine hydrochloride and Phenylephrine hydrochloride SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50580-781
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 12.5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
CARBOXYMETHYLCELLULOSE SODIUM
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
water
SODIUM BENZOATE
SODIUM CITRATE
sorbitol
Sucralose

Product Characteristics

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:50580-781-04 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2008-08-01


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Be sure to consult your doctor before taking any medication!
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