STONA-S- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Sato Pharmaceutical Co., Ltd.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purposes Acetaminophen    Pain reliever-fever reducer Chlorpheniramine maleate    Antihistamine Dextromethorphan hydrobromide    Cough suppressant Phenylephrine hydrochloride         Nasal decongestant     Uses ■temporarily relieves these symptoms due to a cold, the flu, or hay fever:     ■minor aches and pains  ■headache  ■sore throat  ■nasal congestion     ■runny nose  ■sinus congestion and pressure     ■cough due to minor throat and bronchial irritation     ■sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever ■temporarily reduces fever

Authorization status:

OTC monograph final

Summary of Product characteristics

STONA-S- ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN
HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE CAPSULE
SATO PHARMACEUTICAL CO., LTD.
----------
STONA-S CAPSULES
ACTIVE INGREDIENTS (in each capsule)
Acetaminophen 162.5 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan hydrobromide 10mg
Phenylephrine hydrochloride 5 mg
PURPOSES
Acetaminophen Pain reliever-fever reducer
Chlorpheniramine maleate Antihistamine
Dextromethorphan hydrobromide Cough suppressant
Phenylephrine hydrochloride Nasal decongestant
USES
■temporarily relieves these symptoms due to a cold, the flu, or hay
fever:
■minor aches and pains ■headache ■sore throat ■nasal
congestion
■runny nose ■sinus congestion and pressure
■cough due to minor throat and bronchial irritation
■sneezing, itching of the nose or throat, and itchy, watery eyes due
to hay fever
■temporarily reduces fever
WARNINGS
Liver warning: This product contains acetaminophen. Severe liver
damage may occur if
you take:
■more than 12 capsules in 24 hours, which is the maximum daily
amount for this
product
■with other drugs containing acetaminophen
■3 or more alcoholic drinks everyday while using this product
DO NOT USE
■ with any other drug containing acetaminophen (prescription or
nonprescription). If
you
are not sure whether a drug contains acetaminophen, ask a doctor or
pharmacist.
■ if you are now taking a prescription monoamine oxidase inhibitor
(MAOI) (certain
drugs for
depression, psychiatric or emotional conditions, or Parkinson’s
disease). If you do not
know whether a prescription drug contains an MAOI, ask a doctor or
pharmacist.
■ for 2 weeks after stopping the MAOI drug
ASK A DOCTOR BEFORE USE IF YOU HAVE
■ liver disease ■ heart disease ■ high blood pressure ■
diabetes
■ thyroid disease ■ glaucoma
■ difficulty in urination due to enlargement of the prostate gland
■ a breathing problem such as emphysema or chronic bronchitis
■ a persistent or chronic cough such as occurs with smoking, asthma,
or emphysema,
or if cou