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

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Childrens Benadryl ALLERGY

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

children's Benadryl ALLERGY


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Childrens Benadryl ALLERGY 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

Warnings

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 the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in 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; tsp = teaspoonful
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
Age (yr) Dose (mL or tsp)
children under 2 years do not use
children 2 to 5 years do not use unless directed by a doctor
children 6 to 11 years 5 mL (1 tsp) to 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 14 mg
  • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
  • do not use if bottle wrap, or foil inner seal imprinted "SAFETY SEAL®" is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions or comments?

call 1-877-717-2824

PRINCIPAL DISPLAY PANEL

NDC 50580-534-08

children's
Benadryl
® ®

ALLERGY
Diphenhydramine HCl
12.5 mg/5 mL oral solution
Antihistamine

Relieves

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

Cherry
FLAVORED LIQUID
Alcohol Free

THE HISTAMINE
BLOCKER
®

8 fl oz
(236 ml)

Childrens Benadryl ALLERGY

Childrens Benadryl ALLERGY

Diphenhydramine hydrochloride SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50580-534
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 12.5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
D&C RED NO. 33
FD&C RED NO. 40
GLYCERIN
AMMONIUM GLYCYRRHIZATE
POLOXAMER 407
water
SODIUM BENZOATE
SODIUM CHLORIDE
SODIUM CITRATE
SUCROSE

Product Characteristics

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 236 in 1 BOTTLE
3 236 in 1 BOTTLE
4 1 in 1 CARTON
5 NDC:50580-534-16 2 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2008-07-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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