ACCUHIST DROPS  - phenylephrine hydrochloride and chlorpheniramine maleate solution 
Tiber Laboratories LLC

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Accuhist Drops - Chlorpheniramine Maleate and Phenylephrine Hydrochloride Solution

OTC - ACTIVE INGREDIENT

Phenylephrine Hydrochloride  2.5 mg/1mL: decongestant; Chlorpheniramine Maleate  1.0 mg/1mL: antihistamine

OTC - PURPOSE

Temporarily relieves: runny nose; reduces sneezing; itching of the nose or throat; itchy, watery eyes due to hay fever or other upper respiratory allergies; nasal congestion due to the common cold; temporarily restores free breathing through the nose

WARNINGS

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

USAGE

2-6 years: = (1 mL) every 4 to 6 hours
6-12 years: = (2 mL) every 4 to 6 hours
Do not exceed 4 doses during a 24-hour period or as directed by a doctor.
Keep this and all drugs out of the reach of children.

Other Information:  Store at controlled room temperature 20° – 25°C (68° – 77°F)

INACTIVE INGREDIENT

Cherry Flavor, Citric Acid USP, Glycerin USP, Purified Water, Sodium Benzoate USP, 70% Sorbitol Solution USP.

Questions? Call 678-208-0388 24 hours a day, 7 days a week.

Under Federal Law, AccuHist Drops are available without a prescription.  Certain laws may differ.

Manufactured for:

Tiber Laboratories, LLC.

Suwanee, GA 30024

Rev. 10/09 030-21 P0359

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACCUHIST DROPS  2.5 mg phenylephrine hydrochloride, 1mg chrlorpheniramine maleate per 1 ml oral solution   solution

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 23589-030 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg  in 1 mL CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 1 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE   GLYCERIN   WATER   SODIUM BENZOATE   SORBITOL

Product Characteristics Color      Score      Shape Size Flavor CHERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 23589-030-02 59.2 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/25/2010

Labeler - Tiber Laboratories LLC (008913939)

Registrant - Gorbec Pharmaceutical Services Inc. (791919678)

Establishment
Name	Address	ID/FEI	Operations
Gorbec Pharmaceutical Services Inc.		791919678	MANUFACTURE

Revised: 01/2010Tiber Laboratories LLC