DIMETANE DX- brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide syrup 
Creekwood Pharmaceuticals Inc.

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.

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Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Brompheniramine Maleate 2 mg
Pseudoephedrine Hydrochloride 30 mg
Dextromethorphan Hydrobromide 10 mg

Purpose

Antihistamine
Decongestant
Antitussive

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

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 information

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

Berry 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 PACKAGING

The 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 Syrup Packaging



Dimetane DX Syrup Packaging



Dimetane DX Syrup Packaging




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
Document Id: 95627036-a0bc-469a-9e00-af6544f89a9d
Set id: 89beae5d-67ca-4da3-ae81-2cd59f27c618
Version: 1
Effective Time: 20110304
 
Creekwood Pharmaceuticals Inc.