Stona-s Capsules

Stona-s Capsules
SPL v8
SPL
SPL Set ID 2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1
Route
ORAL
Published
Effective Date 2016-08-19
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
Calcium Phosphate, Dibasic, Anhydrous Fd&c Blue No. 2 Aluminum Oxide Fd&c Yellow No. 6 Gelatin Magnesium Stearate Cellulose, Microcrystalline Polysorbate 80 Starch, Corn Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: SATO;SATO Shape: capsule Color: orange Color: brown Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-09-27

Description

Active ingredients (in each capsule)     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 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

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 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

Description

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

Section 42232-9

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

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.

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 55106-9

Active ingredients (in each capsule)    

Acetaminophen 162.5 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan hydrobromide 10mg

Phenylephrine hydrochloride 5 mg

Section 60561-8

Other information

■keep container tightly closed  ■protect from light  ■store between 15° to 30°C (59° to

  86° F)

■each capsule contains calcium 10 mg


Structured Label Content

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 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

Warnings and Precautions (34071-1)

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

Section 42232-9 (42232-9)

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

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.

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 55106-9 (55106-9)

Active ingredients (in each capsule)    

Acetaminophen 162.5 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan hydrobromide 10mg

Phenylephrine hydrochloride 5 mg

Section 60561-8 (60561-8)

Other information

■keep container tightly closed  ■protect from light  ■store between 15° to 30°C (59° to

  86° F)

■each capsule contains calcium 10 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)