Medication Guide App

Dimetane DX

Dosage form: syrup
Ingredients: Brompheniramine Maleate 2mg in 5mL, Pseudoephedrine Hydrochloride 30mg in 5mL, Dextromethorphan Hydrobromide 10mg in 5mL
Labeler: Creekwood Pharmaceuticals Inc.
NDC Code: 15310-106

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.

Dimetane DX Syrup

Drug Facts Active ingredients
(in each 5 mL teaspoonful)

Brompheniramine Maleate 2 mg
Pseudoephedrine Hydrochloride 30 mg
Dextromethorphan Hydrobromide 10 mg

PurposeAntihistamine
Decongestant
Antitussive

Usestemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • swelling of nasal passages
  • runny nose
  • itchy, watery eyes
  • sneezing

Warnings Do not exceed recommended dosage.

Do not use this product
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), of 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 mellitus
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • 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 sedatives or tranquilizers.

When using this product
  • you may get drowsy
  • avoid alcoholic drinks
  • 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 occurs
  • 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.
  • new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children.

Directions Do not exceed 6 doses in a 24 hour period.
Adults and children
over 12 years of age:
2 teaspoonfuls every
 4 to 6 hours.
Do not exceed
12 teaspoonfuls in a
24 hour period.
Children 6 to under
12 years of age:
1 teaspoonful
every 4 to 6 hours.
Do not exceed
6 teaspoonfuls in a
24 hour period.

Children under 6:
Consult a physician.

Other informationStore at 59° - 86°F (15° - 30°C)

Inactive ingredientsBerry Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?Call 1-866-897-5002

Manufactured for:
Creekwood Pharmaceutical, Inc.
Birmingham, AL 35242

PRODUCT PACKAGINGThe packaging below represents the labeling currently used.

Principal Display Panel and Side Panel for 118 mL Label:

NDC 15310-106-04

Dimetane DX Syrup

Antihistamine
Nasal Decongestant
Antitussive

Each teaspoonful (5 mL) for oral administration contains:

Brompheniramine Maleate................2 mg
Pseudoephedrine HCl.....................30 mg
Dextromethorphan HBr...................10 mg

CREEKWOOD
PHARMACEUTICAL INC.

4 fl oz (118 mL)

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Supplied in a tight, light-resistant container with a child-resistant closure.

Manufactured for:

CREEKWOOD
PHARMACEUTICAL, INC.
Birmingham, AL  35242

Rev. 02/11











DIMETANE  DX
brompheniramine maleate, pseudoephedrine hydrochloride, dextromethorphan hydrobromide syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15310-106
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Brompheniramine Maleate (Brompheniramine) Brompheniramine Maleate2 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride30 mg  in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:15310-106-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/26/2011
Labeler - Creekwood Pharmaceuticals Inc. (618997188)

Revised: 03/2011
 
Creekwood Pharmaceuticals 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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