ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]

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  • ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]

ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]
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NDC 57344-123-02, 57344-123-03, 57344-123-05
Set ID 91ba2b9e-e7f6-4cb6-8f59-5e1095e91b34
Category HUMAN OTC DRUG LABEL
Packager AAA Pharmaceutical, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

    • temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
      • headache
      • sinus congestion and pressure
      • nasal congestion
      • minor aches and pains
    • helps decongest sinus openings and passages
    • promotes sinus drainage
    • helps clear nasal passages
    • temporarily reduces fever
  • Warnings

    Liver warning

    This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen 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). 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland

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

    When using this product do not exceed recommended dosage

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    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

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole – do not crush, chew, or dissolve
    • do not take more than 10 caplets in 24 hours
    children under 12 years
    • ask a doctor
  • Other information

    • store between 20-25°C (68-77°F) in a dry place
    • retain carton for complete product information
  • Inactive ingredients

    acesulfame potassium, colloidal silicon dioxide,croscarmellose sodium, D&C yellow #10, FD&C blue #1, flavor, hypromellose, lactose, magnesium stearate, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    AAA Pharmaceutical, Inc.
    681 Main Street
    Lumberton, NJ 08048

  • PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton

    RESTORE u

    NDC 57344-123-05

    †COMPARE TO THE ACTIVE
    INGREDIENTS IN TYLENOL ® SINUS
    CONGESTION & PAIN - DAYTIME

    See New Warnings
    Information & Directions

    DAY TIME
    NON-DROWSY

    Sinus
    For
    Adults
    CONGESTION & PAIN
    Pain Reliever/Fever Reducer, Nasal Decongestant

    • Sinus Headache – Acetaminophen
    • Nasal Congestion/Sinus Pressure – Phenylephrine HCl

    24 CAPLETS

    Principal Display Panel - 24 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE 
    acetaminophen and phenylephrine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-123
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize17mm
    FlavorMINTImprint Code AAA;1114
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57344-123-052 in 1 CARTON04/30/2012
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/30/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)
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