DESPEC DM TABS- dextromethorphan hydrobromide, guaifenesin and pseudoephedrine hydrochloride tablet
International Ethical Labs

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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Despec-DM Tabs

Drug Facts

Active ingredients

Dextromethorphan HBr 30 mg

Guaifenesin 400 mg

Pseudoephedrine HCl 40 mg

Purpose

Antitussive

Expectorant

Nasal Decongestant

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
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
nasal congestion
reduces swelling of nasal passages

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), 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

a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
a cough that occurs with too much phlegm (mucus)
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
new symptoms occur

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.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:	1 tablet every 6 hours, not to exceed 4 tablets in 24 hours
Children under 12 years of age:	Consult a physician.

Other information

Store at controlled room temperature between 15°-30°C (59°-86°F).

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

Despec DM Tablets are white, oval-shaped tablets, debossed "DESPEC DM" on one side, "IEL" biscet "110" on the other.

Inactive ingredients

Croscarmellose Sodium, Hypromellose, Silicon Dioxide, Siliconized Microcrystalline Cellulose, and Stearic Acid.

Questions? Comments?

Call 1-787-765-3510

Manufactured for:

International Ethical Laboratories

San Juan, PR 00918-2627

Rev. 09/11

Product Packaging

The packaging below represents the label currently used.

Principal display panel and side panel for 60 tablets label:

NDC 11584-1100-6

Despec-DM Tabs

ANTITUSSIVE · EXPECTORANT

NASAL DECONGESTANT

Each tablet contains:

Dextromethorphan HBr........................30 mg

Guaifenesin......................................400 mg

Pseudoephedrine HCl..........................40 mg

Tamper evident by foil seal under cap.

Do not use if foil seal is broken or missing.

Manufactured for:

International Ethical Labs

San Juan, PR 00918-2627

60 tablets

Despec-DM Tabs Packaging

DESPEC DM TABS
dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11584-1100
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	40 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	17mm
Flavor		Imprint Code	IEL;110
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11584-1100-6	60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/08/2011	05/31/2015

Labeler - International Ethical Labs (091176933)

Registrant - Great Southern Laboratories (056139553)

Name	Address	ID/FEI	Business Operations
Establishment
Woodfield Pharmaceutical, LLC		079398730	manufacture(11584-1100)

Revised: 8/2015

Document Id: 1d35cce6-f4ff-0512-e054-00144ff88e88

Set id: d4cc5ab4-abe3-4246-b29b-b1316a007f95

Version: 2

Effective Time: 20150813

International Ethical Labs