Label: STONA-S- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule
- NDC Code(s): 49873-113-01
- Packager: Sato Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 4, 2023
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- ACTIVE INGREDIENT
- PURPOSE
-
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 productDo 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 drugAsk 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 tranquilizersWhen 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 effectStop 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
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
STONA-S
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride capsuleProduct 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 Drug M012 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)
