FDA Label for Dimaphen Dm

View Indications, Usage & Precautions

Dimaphen Dm Product Label

The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each 10 Ml)



Brompheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 10 mg

Phenylephrine HCl, USP 5 mg


Purposes



Antihistamine

Cough suppressant

Nasal decongestant


Uses



  • •temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • •temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • •runny nose
  • •sneezing
  • •itchy, watery eyes
  • •itching of the nose or throat
  • •temporarily restores freer breathing through the nose

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.
  • •to make a child sleepy

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
  • •cough that occurs with too much phlegm (mucus)
  • •a breathing problem such as emphysema or chronic bronchitis
  • •cough that lasts or is chronic such as occurs with smoking, asthma 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
  • •may cause marked drowsiness
  • •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 within 7 days or are accompanied by fever
  • •cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222).


Directions



  • •do not take more than 6 doses in any 24-hour period
  • •measure only with dosage cup provided
  • •keep dosage cup with product
  • •mL = milliliter
  • age

    dose

    adults and children 12 years and over

    20 mL every 4 hours

    children 6 to under 12 years

    10 mL every 4 hours

    children under 6 years

    do not use


Other Information



  • •each 10 mL contains: sodium 4 mg
  • •store at 20°-25°C (68°-77°F)

Inactive Ingredients



anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution


Questions Or Comments?



1-800-616-2471


Principal Display Panel



Children’s

Dimaphen™ DM

ANTIHISTAMINE, Brompheniramine Maleate

COUGH SUPPRESSANT, Dextromethorphan HBr

NASAL DECONGESTANT, Phenylephrine HCl

Relieves – Nasal Symptoms

Stuffy Nose – Runny Nose

Sneezing

Plus Other Symptoms

Itchy, Watery Eyes

Cough

GRAPE FLAVOR

Alcohol-Free

6 yrs. and older

COMPARE TO the active ingredients of DIMETAPP® COLD & COUGH

4 FL. OZ. (118 mL.)


* Please review the disclaimer below.