LOHIST PEB DM- brompheniramine maleate, dextromethorphan hydrobromide 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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LoHist PEB DM

Drug Facts

Active Ingredients

In each 5 mL (1 teaspoonful)

Brompheniramine Maleate, USP 4 mg

Dextromethorphan HBr, USP 20 mg

Phenylephrine HCl, USP 10 mg

Purpose

Antihistamine

Antitussive (cough suppressant)

Nasal decongestant

Uses

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

  • cough due to minor throat and bronchial irritation
  • 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
  • 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
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)

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
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.

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 1 mg sodium per teaspoonful (5 mL)

Inactive Ingredients

Benzoic acid, edetate disodium, FD&C Red #40, propylene glycol, purified water saccharin sodium, sorbitol solution and strawberry flavoring

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-DM label

LOHIST PEB DM 
brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68047-341
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE4 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68047-341-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/06/201101/31/2016
Labeler - Larken Laboratories, Inc. (149484540)
Establishment
NameAddressID/FEIBusiness Operations
Sovereign Pharmaceuticals, LLC623168267manufacture(68047-341)

Revised: 11/2015
 
Larken Laboratories, Inc.