Home > Pill Identifier > APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Capsule

Pill Identifier Information of APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Capsule

Drug Information

APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Capsule

Imprint: 129
Shape: C48345
Color: C48331
Ingredients: Acetaminophen; Phenylephrine
Size: 18.00
Score: 1
Rxtty: SY
Author: SPIRIT PHARMACEUTICALS,LLC
Inactive Ingredients: POLYETHYLENE GLYCOL 400 / PROPYLENE GLYCOL / GELATIN / POVIDONE / SORBITOL / WATER / GLYCERIN / FD&C YELLOW NO. 6>

Complete Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients for DayQuil Sinus (in each LiquiCap)Purpose
    Acetaminophen 325 mgPain reliever
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

    temporarily relieves nasal and sinus symptoms:

    • sinus pain
    • headache
    • nasal and sinus congestion
    • runny nose and sneezing (NyQuil Sinus only)
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 6 doses in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
    • to make a child sleep

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • thyroid disease
    • diabetes
    • high blood pressure
    • trouble urinating due to enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

    When using these products

    • do not use more than directed

    In addition, when using NyQuil Sinus:

    • excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness

    Stop use and ask a doctor if

    • redness or swelling is present
    • symptoms do not get better within 7 days or are accompanied by a fever
    • you get nervous, dizzy or sleepless
    • fever gets worse or lasts more than 3 days
    • new symptoms occur

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

    Keep out of reach of children.

    Overdose warning: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • take only as recommended - see Overdose warning
    • do not exceed 6 doses per 24 hours

    NyQuil Sinus OR DayQuil Sinus

    adults and children
    12 years and over    		2 LiquiCaps with
    water every 4 hours
    children 2 to under 12 years ask a doctor
    children under 2 yearsdo not use
    • when using other DayQuil or NyQuil products, carefully read each label to insure correct dosing
  • Other information

    • store at room temperature
  • Inactive ingredients

    NyQuil Sinus FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide.

    DayQuil Sinus FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide.

  • PRINCIPAL DISPLAY PANEL - 6000 Softgels

    D-Time Sinus Soft Gelatin Capsules
    Each Softgel Contains:
    Acetaminophen USP 325mg
    Phenylephrine HCL USP 5mg

    LOT NO :NDC NO : 68210-1470-6
    MFG DATE :QUANTITY : 6000 Softgels
    EXP. DATE :GROSS WT. :

    WARNING:
    KEEP OUT OF REACH OF CHILDREN

    STORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
    PROTECT FROM LIGHT, MOISTURE AND FREEZING

    THIS BULK SHIPMENT IS INTENDED FOR FURTHER PACKAGING PROCESS ONLY.
    CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT
    CONFORMANCE WITH THE FD & C ACT AND REGULATIONS THEREUNDER.

    MANUFACTURED BY:
    Marksans Pharma Ltd
    VERNA, GOA-403722,
    INDIA.
    CODE : GO/DRUGS/515

    MANUFACTURED FOR:
    SPIRIT PHARMACEUTICALS LLC
    225 LINCOLN HWY, STE 205
    FAIRLESS HILLS, PA 19030
    PH.# 215 943 4000
    FAX.# 215 943 4039

    CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    D TIME SINUS 
    acetaminophen and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1470
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code 129
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-1470-51 in 1 DRUM
    15000 in 1 BAG
    2NDC:68210-1470-61 in 1 DRUM
    26000 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/01/2010
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
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