COUGH BE GONE- dextromethorphan hydrobromide guaifenesin liquid

COUGH BE GONE by

Drug Labeling and Warnings

COUGH BE GONE by is a Otc medication manufactured, distributed, or labeled by RFX Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in 10 ml)

Dextromethorphan Hydrobromide 20 mg

Guaifenesin USP 200 mg

Purpose

Cough suppressant

Expectorant

Uses

■ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold ■ helps loosen phlegm (mucus) and thin bronchial secretions make coughs more productive

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

■cough that occurs with too much phlegm (mucus)

■cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor if

if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding

ask a health professional before

Keep out of reach of children

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

Directions

■do not take more than 6 doses in any 24-hour period

■one dose is one bottle

■this adult product is not intended for use in children under 12 years of age

Age                                                  Dose

adults and children 12 years           one bottle (10 ml) every 4 hours

               and over

children under 12 years                  do not use

Inactive ingredients

Almond oil, Citrus peel, Ginger, Honey, Loquat leaf extract, Licorice, Menthol, Purified water

Package Label

INGREDIENTS AND APPEARANCE

COUGH BE GONE 
dextromethorphan hydrobromide guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76206-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ALMOND OIL (UNII: 66YXD4DKO9)
GINGER (UNII: C5529G5JPQ)
HONEY (UNII: Y9H1V576FH)
ERIOBOTRYA JAPONICA LEAF (UNII: Z02066SV11)
LICORICE (UNII: 61ZBX54883)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	brown (light brown )	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76206-001-01	6 in 1 BOX	01/30/2014
1	NDC: 76206-001-10	10 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/30/2014

Labeler - RFX Pharmaceutical Co., Ltd. (530620871)

Establishment
Name	Address	ID/FEI	Business Operations
RFX Pharmaceutical Co., Ltd.		530620871	manufacture(76206-001)