FDA.reportPublic FDA data

Stona-S Capsules

Manufacturer
Sato Pharmaceutical Co., Ltd.
Effective date
2023-12-04
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:03:16

Label at a glance#

ProductStona-S
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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

OTC - WHEN USING SECTION

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 SECTION

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 SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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 SECTION

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

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1242747acetaminophen 162.5 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN8
1242747acetaminophen 162.5 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD8
1242747APAP 162.5 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-113-01Stona-S1 in 1 CARTONCAPSULE18
49873-113-01Stona-S24 in 1 BOTTLECAPSULE248

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-113STONA-S (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE [SATO PHARMACEUTICAL CO., LTD.]8Current NDC, Legacy NDC, 2 package rows20231205_2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
acetaminophenACTIVE INGREDIENT362O9ITL9D3
chlorpheniramine maleateACTIVE INGREDIENTV1Q0O9OJ9Z3
dextromethorphan hydrobromideACTIVE INGREDIENT9D2RTI9KYH3
phenylephrine hydrochlorideACTIVE INGREDIENT04JA59TNSJ3
acetaminophenACTIVE MOIETY362O9ITL9D3
chlorpheniramineACTIVE MOIETY3U6IO1965U3
dextromethorphanACTIVE MOIETY7355X3ROTS3
phenylephrineACTIVE MOIETY1WS297W6MV3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69333
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92J3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQK3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A83
GELATININACTIVE INGREDIENT2G86QN327L3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I303
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ3
TALCINACTIVE INGREDIENT7SEV7J4R1U3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49873-11349873-113-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
ALUMINUM OXIDELMI26O6933IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYSORBATE 806OZP39ZG8HIACT
STARCH, CORNO8232NY3SJIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
2 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKCAPSULE / ORAL4 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE / ORAL7 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JCAPSULE / ORAL401 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE / ORAL418.37 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE / ORAL418.37 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKCAPSULE / ORAL4 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE / ORAL7 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JCAPSULE / ORAL401 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stona-SACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc12023-12-04WarningsExact identifier
ndc (package): 49873-113-01
ndc (product): 49873-113
ndc11 (package): 49873011301
spl id: 0bb87850-ad34-ce89-e063-6294a90a421d
spl set id: 2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.