STONA COUGH- dextromethorphan hydrobromide, guaifenesin syrup

Stona Cough by

Drug Labeling and Warnings

Stona Cough by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in 10 mL)
Dextromethorphan hydrobromide 30 mg
Guaifenesin 200 mg

PURPOSE

Purpose
Dextromethorphan hydrobromide    Cough suppressant
Guaifenesin    Expectorant

INDICATIONS & USAGE

Uses
For the temporary relief of cough due to the common cold. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

WARNINGS

Enter section text here

Do not use this product

■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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

■for a persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

■if cough is accompanied by excessive phlegm (mucos) unless directed by a doctor.

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, ask a health professional before use.

DOSAGE & ADMINISTRATION

Directions
■Adults and children 12 years of age and over: Take 10mL every 6 – 8 hours, not to exceed 30mL in 24 hours, or as directed by a doctor.
■Children under 12 years: Ask a doctor.

INACTIVE INGREDIENT

Inactive ingredients
alcohol, beta-cyclodextrin, butylparaben, calcium chloride, caramel, citric acid, flavor, glycyrrhiza (licorice) extract, propylparaben, sodium benzoate, sodium saccharin, sugar, water.

PRINCIPAL DISPLAY PANEL

stonacoughsyrcartA.jpg

PRINCIPAL DISPLAY PANEL

stonacoughsyrcartB.jpg

INGREDIENTS AND APPEARANCE

STONA COUGH 
dextromethorphan hydrobromide, guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-302
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
BETADEX (UNII: JV039JZZ3A)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
CARAMEL (UNII: T9D99G2B1R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (cherry brandy) , VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-302-01	1 in 1 CARTON	01/03/2001
1		120 mL in 1 BOTTLE; 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	01/03/2001

Labeler - Sato Pharmaceutical Co., Ltd. (690575642)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-302) , label(49873-302) , pack(49873-302)