Children's

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (1 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

Orange Benzoic Acid Citric Acid Monohydrate Edetate Disodium Fd&c Yellow No. 6 Propylene Glycol Water Sodium Citrate Saccharin Sodium Sorbitol

Identifiers & Packaging

Pill Appearance

Color: orange

Marketing Status

OTC MONOGRAPH FINAL Active Since 2009-11-11

Medication Information

Description

ALLERGY & STUFFY NOSE Drug Facts

Uses

temporarily relieves
- itchy, watery eyes
- runny nose
- itchy nose or throat
- sneezing
- nasal and sinus congestion as may occur with a cold

Section 42229-5

ALLERGY & STUFFY NOSE

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.

Section 50568-5

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

Section 55105-1

Active ingredients (in each 5 mL, 1 teaspoonful)	Purposes
Chlorpheniramine maleate 1 mg	Antihistamine
Phenylephrine HCl 2.5 mg	Nasal decongestant

Directions

may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age.
specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device.

Age	Dose
children under 4 years of age	do not use
children 4 to under 6 years of age	do not use unless directed by a doctor
children 6 to under 12 years of age	1-2 tsp. (5-10 mL)

Do Not Use

in a child under 4 years of age
in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
for the purpose of making your child sleepy

Questions?

877-434-2036

Other Information

each teaspoonful contains: sodium 3 mg
store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

artificial flavor, benzoic acid, citric acid, disodium EDTA, FD&C yellow #6, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

When Using This Product

do not exceed recommended dosage
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occurs
symptoms do not improve within 7 days or occur with a fever. These could be signs of a serious condition.

Principal Display Panel 118 Ml Carton

CHILDREN'S

ACCUDIAL

ROTATING DOSING LABEL

Allergy

& Stuffy Nose

ACCURATE DOSING

BY WEIGHT

Chlorpheniramine maleate

(Antihistamine)

Phenylephrine HCl

(Nasal Decongestant)

Itchy, Watery Eyes

Runny Nose

Stuffy Nose

Sneezing

For Ages 6 to under 12

Compares to

Children's Triaminic^®

Cold & Allergy.

ORANGE

FLAVOR

4 FL. OZ.

(118 mL)

NDC 45014-141-04

Ask A Doctor Before Use If the Child Has

heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
a breathing problem such as asthma or chronic bronchitis

Structured Label Content

Uses

temporarily relieves
- itchy, watery eyes
- runny nose
- itchy nose or throat
- sneezing
- nasal and sinus congestion as may occur with a cold

Section 42229-5 (42229-5)

ALLERGY & STUFFY NOSE

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.

Section 50568-5 (50568-5)

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

Section 55105-1 (55105-1)

Active ingredients (in each 5 mL, 1 teaspoonful)	Purposes
Chlorpheniramine maleate 1 mg	Antihistamine
Phenylephrine HCl 2.5 mg	Nasal decongestant

Directions

may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age.
specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device.

Age	Dose
children under 4 years of age	do not use
children 4 to under 6 years of age	do not use unless directed by a doctor
children 6 to under 12 years of age	1-2 tsp. (5-10 mL)

Do Not Use (Do not use)

in a child under 4 years of age
in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
for the purpose of making your child sleepy

Questions?

877-434-2036

Other Information (Other information)

each teaspoonful contains: sodium 3 mg
store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients (Inactive ingredients)

artificial flavor, benzoic acid, citric acid, disodium EDTA, FD&C yellow #6, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

When Using This Product (When using this product)

do not exceed recommended dosage
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness, or sleeplessness occurs
symptoms do not improve within 7 days or occur with a fever. These could be signs of a serious condition.

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

CHILDREN'S

ACCUDIAL

ROTATING DOSING LABEL

Allergy

& Stuffy Nose

ACCURATE DOSING

BY WEIGHT

Chlorpheniramine maleate

(Antihistamine)

Phenylephrine HCl

(Nasal Decongestant)

Itchy, Watery Eyes

Runny Nose

Stuffy Nose

Sneezing

For Ages 6 to under 12

Compares to

Children's Triaminic^®

Cold & Allergy.

ORANGE

FLAVOR

4 FL. OZ.

(118 mL)

NDC 45014-141-04

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)

heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
a breathing problem such as asthma or chronic bronchitis

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information