FDA Label for Stona Cough

Otc - Active Ingredient

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

Otc - Purpose

Purposes
Dextromethorphan hydrobromide    Cough suppressant

Guaifenesin     Expectorant
Phenylephrine hydrochloride    Nasal decongestant

Indications & 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

Warnings

Warnings

Otc - Do Not Use

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

Otc - Ask Doctor

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are
■ taking a prescription drug and do not know if it contains an MAOI

Otc - When Using

When using this product
■ do not exceed recommended dosage

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

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

Otc - 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.

Dosage & 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

Other Safety Information

Other information
■ each tablet contains calcium 30 mg
■ keep container tightly closed
■ protect from light

Inactive Ingredient

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

Package Label.Principal Display Panel

Carton - StonaCoughCart