ACCUHIST PDX  - chlorpheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride solution 
Tiber Laboratories, LLC

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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Active Ingredients (per 1 mL)

Chlorpheniramine maleate 1 mg
Dextromethorphan hydrobromide 2.5 mg
Phenylephrine hydrochloride 2.5 mg

Purpose

Antihistamine
Cough Suppressant
Nasal Decongestant

Uses

Temporarily relieves:

Warnings

Do not exceed recommended dosage.

If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

May cause excitability, especially in children.

May cause drowsiness; sedatives and tranquilizers may increase this effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's doctor.

Do not give
this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.

Do not give this product for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucous) unless directed by a doctor. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Do not use 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 your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Do not give
this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Directions

Children 6 to 12 years of age: 2 mL every 4 hours
Children under 6 years of age: Consult a physician.
Do not exceed 6 doses during a 24-hour period or as directed by a physician.

Other Information

Store at 20°-25°C (68°-77°F).
Under Federal Law, this product is available without a prescription. Certain laws may differ.

Inactive Ingredients

bubble gum flavor, citric acid, glycerin 99.5% min, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol 70% solution.

Questions? Comments?

Call 1-678-208-0388

carton


ACCUHIST PDX 
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:23589-031
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE1 mg  in 1 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE2.5 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM CITRATE 
SACCHARIN SODIUM 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:23589-031-0259.2 mL in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/25/2010

Labeler - Tiber Laboratories, LLC (008913939)

Revised: 07/2011 Tiber Laboratories, LLC