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

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Allergy and Stuffy Nose

Accudial Pharmaceutical, Inc.

Children's ACCUDIAL


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ALLERGY & STUFFY NOSE

Drug Facts

Active ingredient

Purpose

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

Allergy and Stuffy Nose Uses

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

Warnings

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

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

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

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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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)

Allergy and Stuffy Nose 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.

Questions?

877-434-2036

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

Allergy and Stuffy Nose

Allergy and Stuffy Nose

Chlorpheniramine Maleate and Phenylephrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:45014-141
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 1 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
ORANGE
BENZOIC ACID
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
FD&C YELLOW NO. 6
propylene glycol
water
SODIUM CITRATE
saccharin sodium
sorbitol

Product Characteristics

Color
ORANGE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:45014-141-04 118 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-11-11


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Be sure to consult your doctor before taking any medication!
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