FDA Label for Stona-s

Otc - Active Ingredient

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

Otc - Purpose

Purposes
Acetaminophen    Pain reliever-fever reducer
Chlorpheniramine maleate    Antihistamine
Dextromethorphan hydrobromide    Cough suppressant
Phenylephrine hydrochloride         Nasal decongestant    

Indications & 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

Warnings

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

Otc - Do Not Use

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   

Otc - Ask Doctor

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)

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are
■taking the blood thinning drug warfarin
■taking sedatives or tranquilizers

Otc - When Using

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

Otc - Stop Use

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

Precautions

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

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. Prompt medical attention is critical for adults as well as for
children even if you do not notice any signs or symptoms.

Dosage & 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

Other Safety Information

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

Inactive Ingredient

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.

Package Label.Principal Display Panel

Carton - StonaScart