EXPECTORANT PLUS COUGH RELIEF - guaifenesin and dextromethorphan granule 
Capricorn Pharma 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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Drug Facts

Active Ingredients (in each packet)

Dextromethorphan HBr 5mg

Guaifenesin 100mg


Purpose

Cough Suppressant

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
■ temporarily relieves:
■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
■ the intensity of coughing
■ the impulse to cough to help you get to sleep

Warnings

 

Do not use 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

■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
■ cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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

■ empty entire contents of packet onto tongue and swallow with a glass of water
■ for best taste, do not chew granules
■ do not take more than 6 doses in any 24-hour period

Age
Dose
adults and children 12 years and over
2 to 4 packets every 4 hours
children 6 years to under 12 years
1 to 2 packets every 4 hours
children 4 years to under 6 years
1 packet every 4 hours
children under 4 years
do not use

Other information

■ store between 20-25°C (68-77°F).
■ tamper evident: do not use if carton is open or if packets are torn or open.
■ see below for lot number and expiration date

Inactive Ingredients

cocoa butter, confectioners sugar, crospovidone, lactose, maltodextrin, methacrylic acid copolymer, microcrystalline cellulose, modified cornstarch, flavor, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, sorbitan monostearate, starch, sucralose, sugar, talc, triethyl citrate

Principal Display Panel

Capricorn Pharma
ORIGINAL DEVELOPERS AND MANUFACTURERS

Compare to the active ingredients of Mucinex Cough Mini-Melts

FOR KIDS
For ages 4-12

Expectorant plus Cough Relief

DEXTROMETHORPHAN HBr 5mg - Cough Suppressant
GUAIFENESIN 100mg - Expectorant

Relieves Chest Congestion
Thins and loosens mucus
Controls cough
Great taste, Easy to Take

FLASHBEADS

12 Packets

Orange Flavor

Guaifenesin and Dextromethorphan



EXPECTORANT PLUS COUGH RELIEF 
guaifenesin and dextromethorphan granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66007-204
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg
Product Characteristics
Colorwhite (White to off-white) Score    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66007-204-0112 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/06/2010
Labeler - Capricorn Pharma Inc. (041704524)
Registrant - Capricorn Pharma Inc. (041704524)
Establishment
NameAddressID/FEIBusiness Operations
Capricorn Pharma Inc.041704524manufacture

Revised: 8/2010
Document Id: bfb607f0-1c6a-470c-ad3b-933b3f5897f4
Set id: 98679846-e383-4341-96a7-7df2a35ca5ff
Version: 1
Effective Time: 20100806
 
Capricorn Pharma Inc.