SOOTHE COMFORT I COUGH SYRUP ORIGINAL- dextromethorphan liquid

Soothe Comfort I Cough Syrup by

Drug Labeling and Warnings

Soothe Comfort I Cough Syrup 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 30 ml/2TBSP)

Dextromethorphan 30 mg

Purpose

Cough suppressant

Use

■ 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

■ 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 use

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

■ one dose is two tablespoons (TBSP)

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

Age Dose

adults and children 12 years 30 mL (2TBSP)

and over every 6 hours

children 4 to under 12 years ask a doctor

children under 4 years do not use

Other Information

■ store at 20-25ºC (68-77ºF). Do not refrigerate

Inactive ingredients

astragalus root extract, coltsfoot flower bud extract, epimedium leaf extract, honey, schisandra fruit extract, water, white mulberry root bark extract

Questions or comments?

■ 1-800-860-0888

Package Label

INGREDIENTS AND APPEARANCE

SOOTHE COMFORT I COUGH SYRUP  ORIGINAL
dextromethorphan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76206-004
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
MORUS ALBA ROOT BARK (UNII: SV6B76DK9N)
TUSSILAGO FARFARA FLOWER BUD (UNII: 6WBB6U5V2Q)
HONEY (UNII: Y9H1V576FH)
EPIMEDIUM SAGITTATUM LEAF (UNII: 8H775CGY31)
SCHISANDRA CHINENSIS FRUIT OIL (UNII: 62023A4393)
ASTRAGALUS CANADENSIS ROOT (UNII: 7JS169359F)
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: 76206-004-01	1 in 1 BOX	04/23/2021
1	NDC: 76206-004-05	155 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	04/23/2021

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

Establishment
Name	Address	ID/FEI	Business Operations
RFX Pharmaceutical Co., Ltd.		530620871	manufacture(76206-004)