Stona-S

acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride · Capsule · Oral

Over the counter Histamine-1 Receptor Antagonist Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist

Active ingredient

Active ingredients (in each capsule) Acetaminophen 162.5 mg Chlorpheniramine maleate 2 mg Dextromethorphan hydrobromide 10mg Phenylephrine hydrochloride 5 mg

Purpose

Purposes Acetaminophen Pain reliever-fever reducer Chlorpheniramine maleate Antihistamine Dextromethorphan hydrobromide Cough suppressant Phenylephrine hydrochloride Nasal decongestant

Uses

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

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 cough is accompanied by excessive phlegm (mucus) Ask a doctor or pharmacist before use if you are ■taking the blood thinning drug warfarin ■taking sedatives or tranquilizers When using this product ■do not exceed recommended dosage ■may cause excitability especially in children ■do not drive or operate machinery ■avoid alcoholic beverages ■may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect Stop use and ask a doctor if pain, cough, or nasal congestion gets worse or lasts more than 7 days sore throat persists for more than 2 days nervousness, dizziness, or sleeplessness occur any of the following occurs (these could be signs of a serious condition): fever gets worse or or lasts more than 3 days a severe sore throat sore throat is accompanied or followed by high fever, headache, rash, nausea or vomiting redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts Do not give to children under 12 years of age unless directed by a doctor. 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not use

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

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 cough is accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are ■taking the blood thinning drug warfarin ■taking sedatives or tranquilizers

When using this product

When using this product ■do not exceed recommended dosage ■may cause excitability especially in children ■do not drive or operate machinery ■avoid alcoholic beverages ■may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect

Stop use and ask a doctor

Stop use and ask a doctor if pain, cough, or nasal congestion gets worse or lasts more than 7 days sore throat persists for more than 2 days nervousness, dizziness, or sleeplessness occur any of the following occurs (these could be signs of a serious condition): fever gets worse or or lasts more than 3 days a severe sore throat sore throat is accompanied or followed by high fever, headache, rash, nausea or vomiting redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts

Pregnancy or breast-feeding

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

Keep out of reach of children

Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Directions ■adults and children 12 years of age and older: 2 capsules every 4 hours, while symptoms persist, not to exceed 6 doses (12 capsules) in 24 hours, or as directed by a doctor ■children under 12 years of age: ask a doctor

Inactive ingredients

Inactive ingredients dibasic calcium phosphate, FD and C Blue No. 2 Alminum lake, FD and C Yellow No. 6, FD and C Yellow No. 6 Aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, polysorbate 80, starch, talc, titanium dioxide, and wild cherry extract.

Label text from the FDA structured product label by Sato Pharmaceutical Co., Ltd. (revised Dec 4, 2023). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Stona-S NDC products (1)

NDCStrength & formLabelerType
49873-113Acetaminophen 162.5 mg/1; Chlorpheniramine Maleate 2 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine…
Capsule
Sato Pharmaceutical Co., Ltd.OTC MONOGRAPH DRUG

Frequently asked questions

What is Stona-S used for?

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

Who makes Stona-S?

Stona-S is listed by 1 labeler in the FDA NDC directory, including Sato Pharmaceutical Co., Ltd..