DIMETANE DX- brompheniramine maleate, pseudoephedrine hydrochloride, 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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Dimetane DX Syrup

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:

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 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
brompheniramine maleate, pseudoephedrine hydrochloride, dextromethorphan hydrobromide syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15310-106
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Brompheniramine Maleate (UNII: IXA7C9ZN03) (Brompheniramine - UNII:H57G17P2FN)	Brompheniramine Maleate	2 mg in 5 mL
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)	Pseudoephedrine Hydrochloride	30 mg in 5 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	10 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Sodium Citrate, unspecified form (UNII: 1Q73Q2JULR)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sorbitol (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:15310-106-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/26/2011	01/27/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	02/26/2011	01/27/2012

Labeler - Creekwood Pharmaceuticals Inc. (618997188)

Revised: 11/2016

Document Id: b3639624-a993-4b9e-ad29-58308610d178

Set id: 89beae5d-67ca-4da3-ae81-2cd59f27c618

Version: 2

Effective Time: 20161122

Creekwood Pharmaceuticals Inc.