MyHist DM

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 15mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 7.5mg in 5mL, PYRILAMINE MALEATE 12.5mg in 5mL
Labeler: Larken Laboratories, Inc.
NDC Code: 68047-230

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.

MyHist DM

Drug Facts

Active Ingredients

In each 5 mL (1 teaspoonful) clear, grape flavored liquid

Dextromethorphan HBr, USP 15 mg

Phenylephrine HCl, USP 7.5 mg

Pyrilamine Maleate, USP 12.5 mg

Purpose

Dextromethorphan HBr Cough Suppressant

Phenylephrine HCl Nasal decongestant

Pyrilamine Maleate, USP Antihistamine

Uses

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

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat
nasal congestion
temporarily controls coughs to minor throat and bronchial irritation associated with inhaled irritants
temporarily restores freer breathing through the nose

Warnings

See warnings below

Do not use
in a child under 2 years of age
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 product.

Ask a doctor before use if you have
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
glaucoma
a cough that occurs with too much phlegm
a breathing problem or persistent chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers

When using this product
do not use more than directed
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
you get nervous , dizzy or sleepless
symptoms do not get better or accompanied by fever
cough lasts for more than 7 days, comes back, or is accompanied by 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 right away.

Directions
Adults and children  12 years and older:1 to 2 teaspoonsful every 6 to 8 hours
Children 6 years to under 12 years:1/2 to 1 teaspoonful  every 6 to 8 hours
Children 2 years to under 6 years:Ask your doctor
Children under 2 years:Not Recommended
Do not exceed 4 doses in a 24 hour period

Other information
each teaspoonful contains: sodium 3 mg
store at 20°-25°C (68°-77°F)

Inactive ingredients

citric acid, edetate disodium, grape flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate dihydrate, and sorbitol

Questions or comments?

Call weekdays from 9 AM to 4 PM CST at 1-888-527-5522 or go to http://www.larkenlabs.com

Principal Display Panel

Figure 1: 16 oz. bottle label

MYHIST DM 
dextromethorphan hydrobromide, phenylephrine hydrochloride, and pyrilamine maleate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68047-230
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE7.5 mg  in 5 mL
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
GLYCERIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SACCHARIN SODIUM 
SODIUM CITRATE 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68047-230-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/06/200702/28/2014
Labeler - Larken Laboratories, Inc. (791043719)
Registrant - Larken Laboratories, Inc. (791043719)
Establishment
NameAddressID/FEIOperations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE

Revised: 01/2011
 
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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