Pyril DM

Dosage form: suspension
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 5mg in 5mL, PYRILAMINE MALEATE 16mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 15mg in 5mL
Labeler: Macoven Pharmaceuticals
NDC Code: 44183-210

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.

PYRIL DM

Drug Facts

Active ingredients (in each 5 mL)Purpose
Pyrilamine Maleate 16 mgAntihistamine
Phenylephrine HCl 5 mgNasal Decongestant
Dextromethorphan HBr 15 mgCough Suppressant

Uses

temporarily relieves

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever or other upper respiratory allergies
  • nasal congestion due to the common cold
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the impulse to cough to help you get to sleep

Warnings

  • May cause excitability, especially in children

Do Not Use
  • 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
  • diabetes
  • thyroid disease
  • high blood pressure
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with emphysema, chronic bronchitis, or asthma
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use
  • If you or your child are taking sedatives or tranquilizers

When using this product
  • Do not exceed recommended dosage.
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occurs
  • if symptoms do not improve within 7 days or are accompanied by a fever, rash, or 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. 800-222-1222

Directions
  • take every 6 to 8 hours
  • do not take more than 4 doses in 24 hours or as directed by a doctor
Adults and children 12 years of age and older1 to 2 teaspoonsful
Children 6 to under 12 years of age1 teaspoonful
Children under 6 years of ageAsk a doctor

Other Information

store at controlled room temperature 20°-25°C (68°-77°F)

  • Tamper Evident: Do not use if seal is broken or missing.

Inactive ingredients

Citric acid, FD&C Blue No. 1, FD&C Red No. 40, glycerin, grape flavor, magnesium aluminum silicate, methylparaben, purified water, sucralose, monoammonium glycyrrhizinate, sodium benzoate, sodium citrate dihydrate, sucrose, xanthan gum and galloquinate.

Questions?

Call 1-877-622-6836

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

MACOVEN
PHARMACEUTICALS, LLC

NDC 44183-210-16

PYRIL DM
SUSPENSION

Shake Well

Each 5 mL (one teaspoonful)
for oral administration contains:

Pyrilamine Maleate16 mg
Phenylephrine HCl5 mg
Dextromethorphan HBr15 mg

GRAPE FLAVOR

16 fl. oz. (473 mL)

PYRIL DM 
phenylephrine hydrochloride, pyrilamine maleate, and dextromethorphan hydrobromide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44183-210
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE16 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
GRAPE 
MAGNESIUM ALUMINUM SILICATE 
METHYLPARABEN 
WATER 
SUCRALOSE 
GLYCYRRHIZIN, AMMONIATED 
SODIUM BENZOATE 
SODIUM CITRATE 
SUCROSE 
XANTHAN GUM 
TANNIC ACID 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:44183-210-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/01/2011
Labeler - Macoven Pharmaceuticals (832591965)

Revised: 03/2011
 
Macoven Pharmaceuticals

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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