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 mgAntihistamine
Phenylephrine HCl 2.5 mgNasal decongestant

Uses

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

AgeDose
children under 4 years of agedo not use
children 4 to under 6 years of agedo not use unless directed by a doctor
children 6 to under 12 years of age1-2 tsp. (5-10 mL)

Other information

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-141
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate1 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Orange (UNII: 5EVU04N5QU)  
Benzoic Acid (UNII: 8SKN0B0MIM)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Edetate Disodium (UNII: 7FLD91C86K)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sorbitol (UNII: 506T60A25R)  
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45014-141-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/11/2009
Labeler - Accudial Pharmaceutical, Inc. (831999201)

Revised: 11/2009
Document Id: bd6d673a-27d7-4fa7-9d0f-62a89882ea6e
Set id: 96ebdeec-9f97-44a6-adce-b2e100d3168e
Version: 1
Effective Time: 20091111
 
Accudial Pharmaceutical, Inc.