LOHIST PEB - brompheniramine maleate and phenylephrine hydrochloride liquid 
Larken Laboratories, 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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Drug Facts

Active Ingredients

In each 5 mL (1 teaspoonful) clear, bubblegum flavored liquid
Brompheniramine maleate, USP   4 mg
Phenylephrine HCl, USP   10 mg

Purpose

Brompheniramine Maleate          Antihistamine
Phenylephrine HCl                          Nasal decongestant

Uses

Temporarily relieves these symptoms due to hay fever (allergic rhinitis):

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis.
  • Temporarily restores freer breathing through the nose

Warnings

Do not exceed recommended dosage.

Do not use

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions,orParkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

  • taking any other nasal decongestant or stimulant
  • taking sedatives or tranquilizers

When using this product

  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days, or are accompanied by fever

If pregnant or breast-feeding

  • ask a health professional before use.

Keep out of the reach of children

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

Directions

do not exceed 6 doses in a 24-hour period

AgeDose
Adults and children over 12 years of age1 teaspoonful (5 mL) every 4 to 6 hours
Children 6 to under 12 years of age1/2 teaspoonful (2.5 mL) every 4 to 6 hours
Children under 6 years of ageAsk your doctor

Other Information

store at 20°-25°C (68°-77°F)

Inactive Ingredients

Benzoic acid, bubblegum flavoring, citric acid, edetate disodium, glycerin, propylene glycol, purified water, saccharin sodium, sodium citrate dihydrate and sorbitol solution

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: 16 oz label (front side)

62503ee4-figure-01

LOHIST PEB 
brompheniramine maleate and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68047-340
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE4 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM CITRATE 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68047-340-16473 mL in 1 BOTTLE
2NDC:68047-340-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/06/2011
Labeler - Larken Laboratories, Inc. (791043719)
Registrant - Larken Laboratories, Inc. (791043719)
Establishment
NameAddressID/FEIBusiness Operations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE

Revised: 01/2011
Document Id: 62503ee4-f9ae-4e3b-8940-d20e47b0e14d
Set id: 0f4bc679-f4cf-44c3-b712-39995d8d951b
Version: 1
Effective Time: 20110106
 
Larken Laboratories, Inc.