DESPEC-DM TABS- dextromethorphan hydrobomide, guaifenesin, pseudoephedrine hydrochloride tablet
Internatiional 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.

----------

Despec-DM Tabs

Drug Facts

Active ingredients

(in each tablet)

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Pseudoephedrine HCl 30 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:

2 tablets every 4 hours.

not to exceed 8 tablets

in 24 hours.

Children 6 to under 12

years of age:

1 tablet every 4 hours,

not to exceed 4 tablets

in 24 hours.

Children 2 to under 6

years of age:

1/2 tablet every 4 hours,

not to exceed 2 tablets

in 24 hours.

Children under 2 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" bisect "110" on the other.

Inactive ingredients

collodial silicon dioxide, croscarmellose sodium, hypromellose, maltodextrin, povidone, silicified microcrystalline cellulose, and stearic acid. May also contain sodium starch glycolate.

Questions? Comments?

Call 1-787-765-3510

Manufactured for:

International Ethical Laboratories

San Juan, PR 00918-2627

Rev. 07/14

PRODUCT LABELING

Despec DM Tabs Despec DM Tabs2

DESPEC-DM TABS
dextromethorphan hydrobomide, guaifenesin, pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11584-1101
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
STEARIC ACID (UNII: 4ELV7Z65AP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE (UNII: FZ989GH94E)

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:11584-1101-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/25/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/25/2014	04/30/2018

Labeler - Internatiional Ethical Labs (091176933)

Name	Address	ID/FEI	Business Operations
Establishment
Woodfield Pharmaceutical, LLC		079398730	manufacture(11584-1101)

Revised: 5/2018

Document Id: 6b64827b-d608-3aea-e053-2a91aa0ab5e1

Set id: 18043cd4-1062-6059-e054-00144ff88e88

Version: 2

Effective Time: 20180504

Internatiional Ethical Labs