Stona Cough Tablet

Manufacturer: Sato Pharmaceutical Co., Ltd.
Effective date: 2023-12-04
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 00:03:17

Label at a glance#

ProductStona Cough

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purposes
Dextromethorphan hydrobromide Cough suppressant

Guaifenesin Expectorant
Phenylephrine hydrochloride Nasal decongestant

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

OTC - DO NOT USE SECTION

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 SECTION

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 SECTION

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 SECTION

When using this product
■ do not exceed recommended dosage

OTC - STOP USE SECTION

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 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.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1245616	dextromethorphan hydrobromide 15 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral Tablet	dextromethorphan hydrobromide 15 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1245616	dextromethorphan HBr 15 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	7
1245616	dextromethorphan hydrobromide 15 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	7

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49873-306-01	Stona Cough	24 in 1 BOTTLE	TABLET	24		7
49873-306-01	Stona Cough	1 in 1 CARTON	TABLET	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49873-306	STONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	7	Current NDC, Legacy NDC, 2 package rows	20231205_afc95c82-18da-487b-b4bb-51e0be0378da.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	2
CARBOXYMETHYLCELLULOSE	INACTIVE INGREDIENT	05JZI7B19X	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	2
LICORICE	INACTIVE INGREDIENT	61ZBX54883	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

Stona Cough
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
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
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49873-306	49873-306-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AMMONIA	5138Q19F1X	IACT
CALCIUM CARBONATE	H0G9379FGK	IACT
CARBOXYMETHYLCELLULOSE	05JZI7B19X	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
SHELLAC	46N107B71O	IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	L11K75P92J	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
LICORICE	61ZBX54883	IACT
HYDROXYPROPYL CELLULOSE	RFW2ET671P	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYVINYL ALCOHOL	532B59J990	IACT
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
DIMETHICONE	92RU3N3Y1O	IACT
SUCROSE	C151H8M554	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB

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 · 42 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET / ORAL		2240 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	TABLET / ORAL		165 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE	CARBOXYMETHYLCELLULOSE	05JZI7B19X	TABLET / ORAL	45 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET / ORAL		112 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	TABLET / ORAL	NA		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET / ORAL		793 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET / ORAL		112 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL		4384 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL		4384 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	TABLET / ORAL	NA		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET / ORAL		793 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET / ORAL		2240 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	TABLET / ORAL		165 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET / ORAL		230 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE	CARBOXYMETHYLCELLULOSE	05JZI7B19X	TABLET / ORAL	45 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET / ORAL		230 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stona Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	afc95c82-18da-487b-b4bb-51e0be0378da	2023-12-04	Warnings	Exact identifier ndc (package): 49873-306-01 ndc (product): 49873-306 ndc11 (package): 49873030601 spl id: 0bb8901e-89d4-b026-e063-6294a90ae77a spl set id: afc95c82-18da-487b-b4bb-51e0be0378da

Reported adverse events (FAERS/openFDA)#

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