EXPECTORANT PLUS COUGH RELIEF- guaifenesin and dextromethorphan granule

Expectorant plus Cough Relief by

Drug Labeling and Warnings

Expectorant plus Cough Relief by is a Otc medication manufactured, distributed, or labeled by Capricorn Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

EXPECTORANT PLUS COUGH RELIEF 
guaifenesin and dextromethorphan granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66007-204
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg

Product Characteristics
Color	white (White to off-white)	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66007-204-01	12 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/06/2010

Labeler - Capricorn Pharma Inc. (041704524)

Registrant - Capricorn Pharma Inc. (041704524)

Establishment
Name	Address	ID/FEI	Business Operations
Capricorn Pharma Inc.		041704524	manufacture