ALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERICAN SALES COMPANY]

ALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERICAN SALES COMPANY]
PDF | XML

NDC 41520-601-02
Set ID 4d4ce2b1-8be4-4583-a0b3-a6883137c61c
Category HUMAN OTC DRUG LABEL
Packager AMERICAN SALES COMPANY
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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

    Allergy alert

    Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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
    • 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

    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
    • 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, flavor, hypromellose, iron oxide ochre, lactose anhydrous, magnesium stearate, povidone, pregelatinized starch, propylene glycol, stearic acid, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    NDC 41520-601-02

    CareOne®

    For Adults

    Allergy Multi-Symptom

    Pain Reliever – Acetaminophen

    Nasal Decongestant - Phenylephrine HCl

    Antihistamine – Chlorpheniramine Maleate

    May Cause Drowsiness

    Instant Cooling Sensation

    For the Relief of:

    Headache

    Sinus Pressure; Nasal Congestion

    Runny Nose; Sneezing

    Itchy, Watery Eyes

    Our Pharmacists Recommend

    24 Cool Taste Caplets

    image description

  • INGREDIENTS AND APPEARANCE
    ALLERGY MULTI-SYMPTOM 
    acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-601
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED 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:41520-601-022 in 1 CARTON08/01/201106/30/2022
    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 finalpart34108/01/201106/30/2022
    Labeler - AMERICAN SALES COMPANY (809183973)

Related Drugs