DESPEC- guaifenesin, phenylephrine hydrochloride liquid
International Ethical Laboratories, 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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DESPEC LIQUID

Drug Facts

Active ingredients

( in each 5 mL teaspoonful)

Guaifenesin 100 mg

Phenylephrine Hydrochloride 5 mg

Purpose

Expectorant

Nasal Decongestant

Uses

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

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 older:	2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours.
Children 6 to under 12 years of age:	1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours.
Children under 6 years of age:	Consult a doctor.

Other information

Store at 59 o - 86 oF (15 o - 30 o C)

Inactive ingredients

Glycerin, Grape Flavor, Maltitol, Propylene Glycol, Purified Water, Sodium Saccharin, Sorbitol.

Questions? Comments?

Call 1-787-765-3510.

Manufactured for:
International Ethical Laboratories, Inc.
San Juan, Puerto Rico 00918-2627

TTTT

DESPEC
guaifenesin, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11584-1032
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11584-1032-6	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2002	07/25/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	04/02/2002	07/25/2015

Labeler - International Ethical Laboratories, Inc. (091176933)

Registrant - International Ethical Laboratories, Inc. (091176933)

Revised: 2/2018

Document Id: 651999f6-6591-1682-e053-2991aa0a9e0e

Set id: 5e7c3fe6-ea77-4472-8a4c-4a015ad01fd5

Version: 3

Effective Time: 20180213

International Ethical Laboratories, Inc.