Children's

Children's
SPL v1
SPL
SPL Set ID 04e38dab-16b1-4848-9dcb-92e9f67e6119
Route
ORAL
Published
Effective Date 2011-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Citric Acid Monohydrate Sodium Benzoate Glycerin Polyethylene Glycols Sodium Citrate Sodium Chloride

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-09-01

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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).

Section 50568-5

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

Directions
  • 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
  • children under 2 years: do not use
  • children 2 to 5 years: do not use unless directed by a doctor
  • children 6 to 12 years: 5 to 10 mL (1 to 2 tsp)
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions?

Adverse drug event call (888) 933-3222

Other Information
  • each teaspoon contains: sodium 14 mg
  • store between 20 to 25°C (68 to 77°F)
  • protect from light
  • store in outer carton until contents sused.
Inactive Ingredients

anhydrous citric acid, D&C res #33, FD&C red #40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Ask A Doctor Before Use
  • if the child has a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet
When Using This Product
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Active Ingredient (in Each 5 Ml Tsp)

Diphenhydramine HCl 12.5 mg

Principal Display Panel 118 Ml Bottle Carton

Children's

ALLERGY

RELIEF

HealthSelect ®

Diphenhydramine HCl

Antihistamine

For Temporary Relief of:

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

For Ages 12 and Older

Alcohol Free

NET 4 FL OZ

(118 ML)

NDC 49743-3001-1


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 50568-5 (50568-5)

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

Purpose

Antihistamine

Directions
  • 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
  • children under 2 years: do not use
  • children 2 to 5 years: do not use unless directed by a doctor
  • children 6 to 12 years: 5 to 10 mL (1 to 2 tsp)
Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions?

Adverse drug event call (888) 933-3222

Other Information
  • each teaspoon contains: sodium 14 mg
  • store between 20 to 25°C (68 to 77°F)
  • protect from light
  • store in outer carton until contents sused.
Inactive Ingredients

anhydrous citric acid, D&C res #33, FD&C red #40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Ask A Doctor Before Use (Ask a doctor before use)
  • if the child has a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet
When Using This Product (When using this product)
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Active Ingredient (in Each 5 Ml Tsp) (Active ingredient (in each 5 mL tsp))

Diphenhydramine HCl 12.5 mg

Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 ML Bottle Carton)

Children's

ALLERGY

RELIEF

HealthSelect ®

Diphenhydramine HCl

Antihistamine

For Temporary Relief of:

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

For Ages 12 and Older

Alcohol Free

NET 4 FL OZ

(118 ML)

NDC 49743-3001-1


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)