STONA COUGH- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet

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 each tablet)
Dextromethorphan hydrobromide 15mg
Guaifenesin 100 mg
Phenylephrine hydrochloride 5 mg

PURPOSE

Purposes
Dextromethorphan hydrobromide    Cough suppressant

Guaifenesin     Expectorant
Phenylephrine hydrochloride    Nasal decongestant

INDICATIONS & USAGE

Uses
■ for the temporary relief of cough and nasal congestion due to the common cold
■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

WARNINGS

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)
■ for 2 weeks after the stopping the MAOI drug

Ask a doctor before use if you have
■ heart disease    ■ thyroid disease
■ high blood pressure    ■ high fever    ■ diabetes
■ difficulty in urination due to enlarged prostate gland
■ cough accompanied by excessive phlegm (mucus)
■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are
■ taking a prescription drug and do not know if it contains an MAOI

When using this product
■ do not exceed recommended dosage

Stop use and ask a doctor if
■ symptoms persist for more than 1 week or cough tends to recur (a persistent cough may be sign of a serious condition)
■ nervousness, dizziness, or sleeplessness occur
■ cough is accompanied by rash or persistent headache
■ symptoms are accompanied by fever

 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.

DOSAGE & ADMINISTRATION

Directions
adults and children 12 years of age and over:  take 2 tablets every 6 to 8 hours, not to exceed 8 tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years of age:  take 1 tablet every 6 to 8 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor
children under 6 years of age:  ask a doctor

OTHER SAFETY INFORMATION

Other information
■ each tablet contains calcium 30 mg
■ keep container tightly closed
■ protect from light

INACTIVE INGREDIENT

Inactive ingredients
ammonium hydroxide, anhydrous dibasic calcium phosphate, calcium carbonate, carmellose, carnauba wax, croscarmellose sodium, dewaxed orange shellac, , FDandC Yellow No. 6 aluminum lake as color additive, glycyrrhiza extract, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially hydrolyzed polyvinyl alcohol, polyethylene glycol 6000, propylene glycol, silicon dioxide, simethicone, sugar, talc, titanium dioxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STONA COUGH 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-306
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SHELLAC (UNII: 46N107B71O)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ALUMINUM OXIDE (UNII: LMI26O6933)
LICORICE (UNII: 61ZBX54883)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	SATO;5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-306-01	1 in 1 CARTON	11/24/2004
1		24 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	11/24/2004

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

Establishment
Name	Address	ID/FEI	Business Operations
MeriCal, Inc.		029644978	pack(49873-306) , label(49873-306)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-306)