Home > Pill Identifier > APAP 162.5 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule

Pill Identifier Information of APAP 162.5 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule

Drug Information

APAP 162.5 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule

Imprint: SATO;SATO
Shape: C48336
Color: C48331;C48332
Ingredients: Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine
Size: 19.00
Score: 1
Rxtty: SY
Author: Sato Pharmaceutical Co., Ltd.
Inactive Ingredients: CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS / FD&C BLUE NO. 2 / ALUMINUM OXIDE / FD&C YELLOW NO. 6 / GELATIN / MAGNESIUM STEARATE / CELLULOSE, MICROCRYSTALLINE / POLYSORBATE 80 / STARCH, CORN / TALC / TITANIUM DIOXIDE>

Complete Information

  • 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
    â– 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
    â– temporarily reduces fever

  • WARNINGS

    Warnings
    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
    â– more than 12 capsules in 24 hours, which is the maximum daily amount for this product
    â– with other drugs containing acetaminophen
    â– 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.
    â–  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
    â–  difficulty in urination due to enlargement of the prostate gland
    â–  a breathing problem such as emphysema or chronic bronchitis
    â–  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
    â– taking the blood thinning drug warfarin
    â– taking sedatives or tranquilizers

    When using this product
    â– do not exceed recommended dosage
    â– may cause excitability especially in children
    â– do not drive or operate machinery
    â– avoid alcoholic beverages
    â– 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
    â– 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
    â– 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)
    â– 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

    Carton

  • INGREDIENTS AND APPEARANCE
    STONA-S 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-113
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN162.5 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    Colororange, brown (pale yellow-brown) Scoreno score
    ShapeCAPSULESize19mm
    FlavorCHERRY (WILD CHERRY EXTRACT) Imprint Code SATO;SATO
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-113-011 in 1 CARTON04/25/2014
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/27/2004
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-113) , label(49873-113) , pack(49873-113)
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