stona tablet

stona tablet
SPL v7
SPL
SPL Set ID 8b89f50d-88f8-4773-92ea-5ada61766056
Route
oral
Published
Effective Date 2018-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (162.5 mg) chlorpheniramine (2 mg) dextromethorphan (10 mg) phenylephrine (5 mg)
Inactive Ingredients
carboxymethylcellulose calcium phosphate, dibasic, anhydrous glycerin hypromelloses magnesium stearate polyethylene glycol 6000 polyvinyl alcohol sucrose titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: SATO;2 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2004-09-29

Description

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


Medication Information

Warnings and Precautions

Warnings

 Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    ■ more than 12 tablets 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

Active Ingredient

Active ingredients (in each tablet)

Acetaminophen 162.5 mg

Chlorpheniramine maleate 2 mg    

Dextromethorphan hydrobromide 10mg

Phenylephrine hydrochloride 5 mg

Indications and Usage

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   

Dosage and Administration

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

                   ■ children under 12 years of age: ask a doctor

Description

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

Section 34072-9

Do not give to children under 12 years of age unless directed by a doctor.

Section 50565-1

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.

Section 50566-9

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

Section 50567-7

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

Section 50568-5

Ask a doctor or pharmacist before use if you are

■ taking the blood thinning drug warfarin   ■ taking sedatives or tranquilizers

Section 50569-3

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)    

Section 50570-1

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

Section 51727-6

Inactive ingredients

anhydrous dibasic calcium phosphate, carmellose, glycerin, hypromellose, magnesium stearate, polyethylene glycol 6000, polyvinyl alcohol, sucrose, titanium dioxide, and wild cherry extract.

Section 51945-4

Section 53414-9

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

Section 55105-1

Purposes

Acetaminophen    Pain reliever-fever reducer

Chlorpheniramine maleate    Antihistamine

Dextromethorphan hydrobromide    Cough suppressant

Phenylephrine hydrochloride    Nasal decongestant

Section 60561-8

Other information

■ keep container tightly closed

■ protect from light

■ store between 15° to 30°C (59° to 86° F)


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

 Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    ■ more than 12 tablets 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

Active Ingredient (55106-9)

Active ingredients (in each tablet)

Acetaminophen 162.5 mg

Chlorpheniramine maleate 2 mg    

Dextromethorphan hydrobromide 10mg

Phenylephrine hydrochloride 5 mg

Indications and Usage (34067-9)

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   

Dosage and Administration (34068-7)

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

                   ■ children under 12 years of age: ask a doctor

Section 34072-9 (34072-9)

Do not give to children under 12 years of age unless directed by a doctor.

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

■ taking the blood thinning drug warfarin   ■ taking sedatives or tranquilizers

Section 50569-3 (50569-3)

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)    

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

anhydrous dibasic calcium phosphate, carmellose, glycerin, hypromellose, magnesium stearate, polyethylene glycol 6000, polyvinyl alcohol, sucrose, titanium dioxide, and wild cherry extract.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Acetaminophen    Pain reliever-fever reducer

Chlorpheniramine maleate    Antihistamine

Dextromethorphan hydrobromide    Cough suppressant

Phenylephrine hydrochloride    Nasal decongestant

Section 60561-8 (60561-8)

Other information

■ keep container tightly closed

■ protect from light

■ store between 15° to 30°C (59° to 86° F)


Advanced Ingredient Data


Raw Label Data

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