STONA-S- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule

Stona-S by

Drug Labeling and Warnings

Stona-S by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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   

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)

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

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

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

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

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STONA-S 
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-113
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	162.5 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange, brown (pale yellow-brown)	Score	no score
Shape	CAPSULE	Size	19mm
Flavor	CHERRY (WILD CHERRY EXTRACT)	Imprint Code	SATO;SATO
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-113-01	1 in 1 CARTON	04/25/2014
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/27/2004

Labeler - Sato Pharmaceutical Co., Ltd. (690575642)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-113) , label(49873-113) , pack(49873-113)