Home > Pill Identifier > APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule

Pill Identifier Information of APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule

Drug Information

APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule

Imprint: RP061
Shape: C48345
Color: C48331
Ingredients: Acetaminophen; Dextromethorphan; Phenylephrine
Size: 21.00
Score: 1
Rxtty: SY
Author: Greenbrier International
Inactive Ingredients: FD&C Red No. 40 / FD&C Yellow No. 6 / gelatin / glycerin / METHYLPARABEN / polyethylene glycols / POVIDONES / propylene glycol / PROPYLPARABEN / water / sorbitol / titanium dioxide>

Complete Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Active ingredients (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

     

  • Purpose

    Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

     

  • Uses

    temporarily relieves common cold/flu symptoms:

    • nasal congestion
    • cough due to minor throat & bronchial irritation
    • sore throat
    • headache
    • minor aches & pains
    • fever
  • Warnings

    Liver warning

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

    • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Sore throat warning

    If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

    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), 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.

    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
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough as occurs with smoking, asthma, or emphysema

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

    When using this product, do not use more than directed.

    Stop use and ask a doctor if
    • you get nervous, dizzy or sleepless
    • symptoms get worse or last more than 5 days (children) or 7 days (adults)
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

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

    Keep out of reach of children.

    Overdose warning

    Taking more than directed 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 & for children even if you do not notice any signs or symptoms.

  • Directions

    • take only as directed - see Overdose Warning
    • do not exceed 4 doses per 24 hrs
    adults & children 12 yrs & over2 LiquiCaps with water every 4 hrs
    children 4 to under 12 yrsask a doctor
    children under 4 yrsdo not use
  • Other information

    • store at room temperature
  • Inactive ingredients

    FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, methyl paraben, polyethylene glycol, povidone, propylene glycol, propyl paraben, purified water, sorbitol, titanium dioxide

  • Questions?

    1-866-467-2748

  • SPL UNCLASSIFIED SECTION


    Distributed by:

    Greenbrier International, Inc.

    Chesapeake, VA 23320

  • PRINCIPAL DISPLAY PANEL - 10 Softgel Carton

    Multi-Symptom

     DayTime

    Liquid Capsules

    Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine HCl

     

    Cold/Flu Relief

    • Pain Reliever
    • Fever Reducer
    • Nasal Decongestant
    • Cough Suppressant

     

    10 Softgels

    Compare to the active ingredient in Vicks Dayquil®

    Daytime Liquid Capsules Cold/Flu Relief 10ct
  • INGREDIENTS AND APPEARANCE
    DAYTIME  MULTI-SYMPTOM COLD/FLU RELIEF
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0611
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 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
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    gelatin (UNII: 2G86QN327L)  
    glycerin (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    polyethylene glycols (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    propylene glycol (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    sorbitol (UNII: 506T60A25R)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code RP061
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-0611-01 in 1 CARTON
    110 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/01/2013
    Labeler - Greenbrier International (610322518)
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