LoHist DM

Dosage form: liquid
Ingredients: BROMPHENIRAMINE MALEATE 2mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 5mL
Labeler: Larken Laboratories, Inc.
NDC Code: 68047-129

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 DM

Drug Facts

Active ingredients

(In each 5 mL teaspoonful)

Brompheniramine Maleate, USP   2 mg

Dextromethorphan HBr, USP   10 mg

Phenylephrine HCl, USP   5 mg

Purpose

Brompheniramine Maleate          Antihistamine

Dextromethorphan HBr                Antitussive (cough suppressant)

Phenylephrine HCl                         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, or associated with sinusitis.
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 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 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 the 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

AgeDose
Adults and children over 12 years of age2 teaspoonsful (10 mL) every 4 hours
Children 6 to under 12 years of age1 teaspoonful (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 DM 
brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68047-129
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE2 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
EDETATE DISODIUM 
FD&C RED NO. 40 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM DIHYDRATE 
SORBITOL 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68047-129-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/2012
Labeler - Larken Laboratories, Inc. (791043719)
Establishment
NameAddressID/FEIOperations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE

Revised: 05/2012
 
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.

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