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Name:Allergy And Stuffy Nose
Manufacturer:Accudial Pharmaceutical, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Children's ACCUDIAL

ALLERGY AND STUFFY NOSE - chlorpheniramine maleate and phenylephrine hydrochloride liquid 
Accudial Pharmaceutical, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Children's
ACCUDIAL

ALLERGY & STUFFY NOSE

Drug Facts

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

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)

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

Principal Display Panel - 118 mL Carton

ALLERGY AND STUFFY NOSE 
chlorpheniramine maleate and phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG 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) Chlorpheniramine Maleate 1 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 2.5 mg  in 5 mL
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 Score     
Shape Size
Flavor ORANGE Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45014-141-04 118 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 11/11/2009

Labeler - Accudial Pharmaceutical, Inc. (831999201)

Revised: 11/2009 Accudial Pharmaceutical, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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