Stona Cough Tablet

Stona Cough Tablet
SPL v7
SPL
SPL Set ID afc95c82-18da-487b-b4bb-51e0be0378da
Route
ORAL
Published
Effective Date 2018-02-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg) Guaifenesin (100 mg) Phenylephrine (5 mg)
Inactive Ingredients
Ammonia Calcium Carbonate Carboxymethylcellulose Carnauba Wax Croscarmellose Sodium Shellac Calcium Phosphate, Dibasic, Anhydrous Fd&c Yellow No. 6 Aluminum Oxide Licorice Hydroxypropyl Cellulose Hypromelloses Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Polyvinyl Alcohol Polyethylene Glycol 6000 Propylene Glycol Silicon Dioxide Dimethicone Sucrose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: SATO;5 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-11-24

Description

Active ingredients (in each tablet) Dextromethorphan hydrobromide 15mg Guaifenesin 100 mg Phenylephrine hydrochloride 5 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

■ for the temporary relief of cough and nasal congestion due to the common cold

■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and Administration

Directions

adults and children 12 years of age and over:  take 2 tablets every 6 to 8 hours, not to exceed 8 tablets in 24 hours, or as directed by a doctor

children 6 to under 12 years of age:  take 1 tablet every 6 to 8 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor

children under 6 years of age:  ask a doctor

Description

Active ingredients (in each tablet) Dextromethorphan hydrobromide 15mg Guaifenesin 100 mg Phenylephrine hydrochloride 5 mg

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

■ symptoms persist for more than 1 week or cough tends to recur (a persistent cough may be sign of a serious condition)

■ nervousness, dizziness, or sleeplessness occur

■ cough is accompanied by rash or persistent headache

■ symptoms are accompanied by fever

Section 50567-7

When using this product

■ do not exceed recommended dosage



Section 50568-5

Ask a doctor or pharmacist before use if you are

■ taking a prescription drug and do not know if it contains an MAOI

Section 50569-3

Ask a doctor before use if you have

■ heart disease    ■ thyroid disease

■ high blood pressure    ■ high fever    ■ diabetes

■ difficulty in urination due to enlarged prostate gland

■ cough accompanied by excessive phlegm (mucus)

■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Section 50570-1

Do not use

■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease)

■ for 2 weeks after the stopping the MAOI drug

Section 51727-6

Inactive ingredients

ammonium hydroxide, anhydrous dibasic calcium phosphate, calcium carbonate, carmellose, carnauba wax, croscarmellose sodium, dewaxed orange shellac, , FDandC Yellow No. 6 aluminum lake as color additive, glycyrrhiza extract, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially hydrolyzed polyvinyl alcohol, polyethylene glycol 6000, propylene glycol, silicon dioxide, simethicone, sugar, talc, titanium dioxide

Section 51945-4

Section 53414-9

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



Section 55105-1

Purposes

Dextromethorphan hydrobromide    Cough suppressant

Guaifenesin     Expectorant

Phenylephrine hydrochloride    Nasal decongestant

Section 55106-9

Active ingredients (in each tablet)

Dextromethorphan hydrobromide 15mg

Guaifenesin 100 mg

Phenylephrine hydrochloride 5 mg

Section 60561-8

Other information

■ each tablet contains calcium 30 mg

■ keep container tightly closed

■ protect from light


Structured Label Content

Indications and Usage (34067-9)

Uses

■ for the temporary relief of cough and nasal congestion due to the common cold

■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and Administration (34068-7)

Directions

adults and children 12 years of age and over:  take 2 tablets every 6 to 8 hours, not to exceed 8 tablets in 24 hours, or as directed by a doctor

children 6 to under 12 years of age:  take 1 tablet every 6 to 8 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor

children under 6 years of age:  ask a doctor

Warnings and Precautions (34071-1)

Warnings

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■ symptoms persist for more than 1 week or cough tends to recur (a persistent cough may be sign of a serious condition)

■ nervousness, dizziness, or sleeplessness occur

■ cough is accompanied by rash or persistent headache

■ symptoms are accompanied by fever

Section 50567-7 (50567-7)

When using this product

■ do not exceed recommended dosage



Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

■ taking a prescription drug and do not know if it contains an MAOI

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ heart disease    ■ thyroid disease

■ high blood pressure    ■ high fever    ■ diabetes

■ difficulty in urination due to enlarged prostate gland

■ cough accompanied by excessive phlegm (mucus)

■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Section 50570-1 (50570-1)

Do not use

■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease)

■ for 2 weeks after the stopping the MAOI drug

Section 51727-6 (51727-6)

Inactive ingredients

ammonium hydroxide, anhydrous dibasic calcium phosphate, calcium carbonate, carmellose, carnauba wax, croscarmellose sodium, dewaxed orange shellac, , FDandC Yellow No. 6 aluminum lake as color additive, glycyrrhiza extract, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially hydrolyzed polyvinyl alcohol, polyethylene glycol 6000, propylene glycol, silicon dioxide, simethicone, sugar, talc, titanium dioxide

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

Dextromethorphan hydrobromide    Cough suppressant

Guaifenesin     Expectorant

Phenylephrine hydrochloride    Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Dextromethorphan hydrobromide 15mg

Guaifenesin 100 mg

Phenylephrine hydrochloride 5 mg

Section 60561-8 (60561-8)

Other information

■ each tablet contains calcium 30 mg

■ keep container tightly closed

■ protect from light


Advanced Ingredient Data


Raw Label Data

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