LoHist PEB

Dosage form: liquid
Ingredients: BROMPHENIRAMINE MALEATE 4mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 5mL
Labeler: Larken Laboratories, Inc.
NDC Code: 68047-340

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 PEB

Drug Facts

Active Ingredients

In each 5 mL teaspoonful

Brompheniramine Maleate, USP 4 mg

Phenylephrine HCl, USP 10 mg

Purpose

Antihistamine

Nasal decongestant

Uses

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

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

Warnings

Do not use

  • to sedate a child or make a child sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two 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 drug.

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

Do not exceed recommended dosage.

  • marked 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
  • if 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 reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

Do not exceed 6 doses in a 24-hour period.

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

Other Information
  • store at 20°-25°C (68°-77°F)
  • very low sodium, contains 4 mg sodium per 5 mL teaspoonful

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 Bottle Label

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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/06/2011
Labeler - Larken Laboratories, Inc. (791043719)
Establishment
NameAddressID/FEIOperations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE(68047-340)

Revised: 04/2013
 
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.

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