Stona Troche

Stona Troche
SPL v6
SPL
SPL Set ID 1ccc9e56-32a4-450f-8412-5814b6aef285
Route
ORAL
Published
Effective Date 2011-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg)
Inactive Ingredients
Cetylpyridinium Chloride Licorice Hydroxypropyl Cellulose Silicon Dioxide Magnesium Stearate Sucrose Aspartame

Identifiers & Packaging

Pill Appearance
Imprint: SATO;SATO Shape: round Color: brown Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 1995-11-19

Description

Active ingredients (in each lozenge) Dextromethorphan HBr 10mg


Medication Information

Warnings and Precautions

Enter section text here

Indications and Usage

Uses temporarily relieves cough due to minor throat and bronchial irritation associated with

■a cold  ■inhaled irritants

Dosage and Administration

Directions

Adults and children 12 years and older - Let 1 or 2 lozenges dissolve slowly in the mouth every 4 hours, not more than 12 lozenges in 24 hours.

Children 6 years to under 12 years - Let 1 lozenge dissolve slowly in the mouth every 4 hours, not more than 6 lozenges in 24 hours.

Children under 6 years - Ask a doctor

■once or twice daily, preferably morning and evening, when needed or as directed by a doctor

■start initial dosage with minimum dose, then adjust it to suit to bowel condition



Description

Active ingredients (in each lozenge) Dextromethorphan HBr 10mg

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.





Section 50568-5

Ask a doctor or pharmacist before use if



■you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Section 50570-1

Do not use



■this product for persistent or chronic cough such as occurs with smoking, asthema, or emphysem, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Section 51727-6

Inactive ingredients  aspartame, cetylpyridinium chloride, flavor, glycyrrhiza, hydroxypropyl cellulose, silicon dioxide, magnesium stearate, sucrose.

Section 51945-4

stonatrochecart.jpg

Section 53414-9

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

Section 55105-1

Purpose

Cough suppressant



Section 55106-9

Active ingredients (in each lozenge)

Dextromethorphan HBr 10mg

Section 60561-8

Other information  

■Phenylketonurics: Contains Phenylalanine (18.3mg) per lozenge.


Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves cough due to minor throat and bronchial irritation associated with

■a cold  ■inhaled irritants

Dosage and Administration (34068-7)

Directions

Adults and children 12 years and older - Let 1 or 2 lozenges dissolve slowly in the mouth every 4 hours, not more than 12 lozenges in 24 hours.

Children 6 years to under 12 years - Let 1 lozenge dissolve slowly in the mouth every 4 hours, not more than 6 lozenges in 24 hours.

Children under 6 years - Ask a doctor

■once or twice daily, preferably morning and evening, when needed or as directed by a doctor

■start initial dosage with minimum dose, then adjust it to suit to bowel condition



Warnings and Precautions (34071-1)

Enter section text here

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.





Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if



■you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Section 50570-1 (50570-1)

Do not use



■this product for persistent or chronic cough such as occurs with smoking, asthema, or emphysem, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Section 51727-6 (51727-6)

Inactive ingredients  aspartame, cetylpyridinium chloride, flavor, glycyrrhiza, hydroxypropyl cellulose, silicon dioxide, magnesium stearate, sucrose.

Section 51945-4 (51945-4)

stonatrochecart.jpg

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Cough suppressant



Section 55106-9 (55106-9)

Active ingredients (in each lozenge)

Dextromethorphan HBr 10mg

Section 60561-8 (60561-8)

Other information  

■Phenylketonurics: Contains Phenylalanine (18.3mg) per lozenge.


Advanced Ingredient Data


Raw Label Data

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