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

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

ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]
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NDC 57344-128-02, 57344-128-06
Set ID 97097bfc-880a-42f9-b4c6-ed3e0be880d7
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
    Chlorpheniramine maleate 2 mgAntihistamine
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

    • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
      • headache
      • sinus congestion and pressure
      • nasal congestion
      • runny nose and sneezing
      • minor aches and pains
    • temporarily relieves these additional symptoms of hay fever:
      • itching of the nose or throat
      • itchy, watery eyes
    • helps clear nasal passages
    • helps decongest sinus openings and passages
  • Warnings

    Liver warning

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

    • more than 12 caplets in 24 hours, which is the maximum daily amount
    • 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.

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin

    When using this product

    • do not exceed recommended dosage
    • excitability may occur, especially in children
    • drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

    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

    Taking more than the recommended dose (overdose) may cause liver damage. 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 12 caplets in 24 hours
    children under
    12 years
    • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
  • 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, flavor, hypromellose, iron oxide ochre, lactose anhydrous, magnesium stearate, povidone, pregelatinized starch, propylene glycol, stearic acid, titanium dioxide

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton

    NDC 57344-128-02

    RESTORE u

    †COMPARE TO THE ACTIVE
    INGREDIENTS IN TYLENOL®
    ALLERGY MULTI-SYMPTOM

    Allergy
    MULTI-SYMPTOM
    Pain Reliever, Nasal Decongestant, Antihistamine

    • Headache - Acetaminophen
    • Sinus Pressure
    • Nasal Congestion
      Phenylephrine HCl
    • Runny Nose/Sneezing
    • Itchy, Watery Eyes
      Chlorpheniramine Maleate

    COOL TASTE

    MAY CAUSE DROWSINESS

    24 CAPLETS

    Principal Display Panel - 24 Caplet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE 
    acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-128
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (Off-White) Scoreno score
    ShapeOVALSize17mm
    FlavorMINTImprint Code AAA;1117
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57344-128-022 in 1 CARTON08/02/2012
    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 finalpart34108/02/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)
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