COUGH MEDICINE SOOTHING RELIEF- dextromethorphan liquid

COUGH MEDICINE by

Drug Labeling and Warnings

COUGH MEDICINE 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 each 10 ml)

Dextromethorphan Hbr, USP 30 mg

Purpose

Cough suppressant

Uses

■ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

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 4 doses in any 24-hour period

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

                Age                                                    Dose

children under 12 years                                do not use

adults and children 12 years                      one bottle (10 ml) 

               and over                                        every 6-8 hours

Other information

■protect from light ■store at 20C-25C (68F-77F)

Inactive ingredients

apricot kernel oil, honey, fritillaria delawayi bulb, water

Package Label

INGREDIENTS AND APPEARANCE

COUGH MEDICINE  SOOTHING RELIEF
dextromethorphan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76206-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
APRICOT KERNEL OIL (UNII: 54JB35T06A)
HONEY (UNII: Y9H1V576FH)
FRITILLARIA DELAVAYI BULB (UNII: AG6Q756AT7)
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: 76206-002-01	6 in 1 BOX
1	NDC: 76206-002-10	10 mL in 1 BOTTLE, GLASS

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(76206-002)