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

Childrens Allergy

Publix Super Markets Inc

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Publix Super Markets, Inc. Children’s Allergy Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL)*

Diphenhydramine HCl 12.5 mg

*5 mL = 1 teaspoon (tsp)

Purpose

Antihistamine

Uses

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

Warnings

Do not use

  • •with any other product containing diphenhydramine, even one used on skin
  • •to make a child sleepy

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
  • •excitability may occur, especially in children
  • •sedatives and tranquilizers may increase drowsiness

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
  • •use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • •take every 4 to 6 hours
  • •do not take more than 6 doses in 24 hours

Age (yr)

Dose

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 to 10 mL (1 to 2 tsp)

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

Other information

  • •each teaspoon contains: sodium 15 mg
  • •store at 20-25°C (68-77°F)

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution

Principal Display Panel

CHILDREN’S

allergy

DIPHENHYDRAMINE HCl

ORAL SOLUTION

ANTIHISTAMINE

Relieves:

sneezing

itchy throat

runny nose

itchy, watery eyes

ALCOHOL-FREE

CHERRY FLAVOR

Compare to Active Ingredient in Children’s Benadryl®

4 FL OZ (118 mL)

Childrens Allergy

Diphenhydramine HCl LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:56062-379
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
HIGH FRUCTOSE CORN SYRUP
POLOXAMER 407
water
SODIUM BENZOATE
SODIUM CHLORIDE
SODIUM CITRATE
sorbitol
GLYCERIN

Product Characteristics

Color
RED (Bluish-Red)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:56062-379-26 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-02-11


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