LOHIST DROPS  - chlorpheniramine maleate and phenylephrine hydrochloride liquid 
Larken Laboratories, Inc.

----------

LoHist Drops

Drug Facts

Active Ingredients

In each 1 mL, cherry flavored liquid

Chlorpheniramine Maleate, USP   1.0 mg

Phenylephrine HCl, USP   2.5 mg

Purpose

Chlorpheniramine Maleate          Antihistamine

Phenylephrine HCl                         Decongestant

Uses

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 freer 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 use

• 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.

Directions

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 out of the reach of children

• In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Other Information

• Store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

Cherry flavor, Citric Acid, Glycerin, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sucralose.

Questions or Comments

Call 1-888-527-5522 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com.

Principal Display Panel

Figure 1: Bottle Label 2 fl. oz. (59.2 mL)

Figure 2: Carton for 2 fl. oz. (59.2mL) bottle

LOHIST DROPS  chlorpheniramine maleate and phenylephrine hydrochloride   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 68047-032 Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID   GLYCERIN   METHYLPARABEN   POTASSIUM CITRATE   POTASSIUM SORBATE   PROPYLPARABEN   PROPYLENE GLYCOL   WATER   SUCRALOSE

Product Characteristics Color      Score      Shape Size Flavor CHERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68047-032-02 1 BOTTLE In 1 CARTON contains a BOTTLE 1 59.2 mL In 1 BOTTLE This package is contained within the CARTON (68047-032-02)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/10/2011

Labeler - Larken Laboratories, Inc. (791043719)

Registrant - Larken Laboratories, Inc. (791043719)

Establishment
Name	Address	ID/FEI	Operations
T.G. United		830980947	MANUFACTURE

Revised: 05/2011Larken Laboratories, Inc.