LoHist

Dosage form: solution/ drops
Ingredients: CHLORPHENIRAMINE MALEATE 1mg in 1mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1mL
Labeler: Larken Laboratories, Inc.
NDC Code: 68047-032

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.

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 
chlorpheniramine maleate and phenylephrine hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68047-032
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE1 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
METHYLPARABEN 
POTASSIUM CITRATE 
POTASSIUM SORBATE 
PROPYLPARABEN 
PROPYLENE GLYCOL 
WATER 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68047-032-021 BOTTLE (BOTTLE) in 1 CARTON
159.2 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/10/201103/31/2013
Labeler - Larken Laboratories, Inc. (791043719)
Registrant - Larken Laboratories, Inc. (791043719)
Establishment
NameAddressID/FEIOperations
T.G. United830980947MANUFACTURE

Revised: 04/2012
 
Larken Laboratories, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)