Stona Cough description, usages, side effects, indications, overdosage, supplying and lots more!

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Stona Cough

Sato Pharmaceutical Co., Ltd.

DRUG FACTS




FULL PRESCRIBING INFORMATION

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

Uses

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

Stona Cough

Stona Cough

dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49873-306
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg
Guaifenesin GUAIFENESIN 100 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
white 11 mm SATO;5 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BOTTLE
2 NDC:49873-306-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2004-11-24


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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