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Stona Cough by Sato Pharmaceutical Co., Ltd.

Dosage form: tablet
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 15mg, GUAIFENESIN 100mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Sato Pharmaceutical Co., Ltd.
NDC Code: 49873-306

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

Active ingredients (in each tablet)
Dextromethorphan hydrobromide 15mg
Guaifenesin 100 mg
Phenylephrine hydrochloride 5 mg

Purposes
Dextromethorphan hydrobromide    Cough suppressant

Guaifenesin     Expectorant
Phenylephrine hydrochloride    Nasal decongestant

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

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.

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

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

STONA COUGH 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-306
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIA 
CALCIUM CARBONATE 
CARBOXYMETHYLCELLULOSE 
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
SHELLAC 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C YELLOW NO. 6 
ALUMINUM OXIDE 
LICORICE 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYVINYL ALCOHOL 
POLYETHYLENE GLYCOL 6000 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
DIMETHICONE 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeSATO;5
Contains    
Packaging
#Item CodePackage Description
1NDC:49873-306-011 BOTTLE in 1 CARTON
124 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/24/2004
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIOperations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-306)
Establishment
NameAddressID/FEIOperations
MeriCal, Inc.029644978pack(49873-306), label(49873-306)

 
Sato Pharmaceutical Co., Ltd.

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Medically reviewed on Feb 16, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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