DESPEC EDA DROPS- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid 
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 EDA Drops

ACTIVE INGREDIENT

Active ingredients:
(in each 1 mL dropperful)
Dextromethorphan Hydrobromide 5 mg
Guaifenesin 50 mg
Phenylephrine Hydrochloride 2.5 mg

PURPOSE

Purpose:

Antitussive
Expectorant
Nasal Decongestant

INDICATIONS & USAGE

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

Warnings:

Do not exceed recommended dosage.

Do not use this product

in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

ASK DOCTOR

Ask a doctor before use if the child has:

a cough that lasts or is chronic such as occurs with asthma
a cough that occurs with too much phlegm (mucus)
heart disease
high blood pressure
thyroid disease
diabetes

STOP USE

Stop use and ask a doctor if:

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.
nervousness, dizziness, or sleeplessness occur

new symptoms occur

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions:

Administer using provided dropper.

AGE

DOSE

Children 2 to under
6 years of age:

1 dropperful (1 mL) every 4 hours,
not to exceed 6 dropperfuls in 24
hours

Children under 2 years of age:

Consult a physician

INACTIVE INGREDIENT

Inactive ingredients:

Bitter Mask, Citric Acid, Glycerin, Grape Flavoring, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose.

OTHER SAFETY INFORMATION

Other information:

Store at 59° - 86°F (15° - 30°C)

QUESTIONS

Questions? Comments?

Call 1-787-765-3510

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Dispensed in a tight, light-resistant container with a child-resistant cap.
Manufactured For:
International Ethical Labs
San Juan, PR 00918-2627

Rev. 04/10/17

Product Packaging

DESPEC EDA DROPS - FRONTDESPEC EDA DROPS - BACK

DESPEC  EDA DROPS
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11584-1110
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 1 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11584-1110-130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/19/2012
Labeler - International Ethical Labs (091176933)
Establishment
NameAddressID/FEIBusiness Operations
Woodfield Pharmaceuticals, LLC079398730manufacture(11584-1110)

Revised: 10/2018
Document Id: 78499d46-0245-544b-e053-2991aa0a69ab
Set id: e8be10f5-8971-4e48-b7b9-ff77b0e43e64
Version: 3
Effective Time: 20181015
 
International Ethical Labs