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DESPEC

International Ethical Laboratories, Inc.
International Ethical Laboratories, Inc.

DESPEC LIQUID


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Guaifenesin 100 mg

Phenylephrine Hydrochloride 5 mg

Purpose

Expectorant

Nasal Decongestant

DESPEC 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. 

DESPEC Other information

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

PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

NDC 11584-1032-6

DESPEC
LIQUID

Expectorant / Nasal Decongestant


Each teaspoonful (5 mL) contains:
Guaifenesin............... 100 mg
Phenylephrine HCl........ 5 mg

Sugar Free / Dye Free / Alcohol Free

Grape Flavor

CONTENTS: 1 PINT (473 mL)


Manufactured For:
INTERNATIONAL ETHICAL LABORATORIES, INC.
San Juan, Puerto Rico  00918-2627


Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

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

THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.

Manufactured by:
Pernix Manufacturing, LLC
Houston, TX 77099

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

Iss. 11/13

DESPECDESPEC

DESPEC

Guaifenesin, Phenylephrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11584-1032
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Guaifenesin GUAIFENESIN 100 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
MALTITOL
propylene glycol
water
saccharin sodium
sorbitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11584-1032-6 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2002-04-02


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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