Label: PHYSICIANSCARE ALLERGY MULTI-SYMPTOM RELIEF- acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated

  • NDC Code(s): 0924-0091-00, 0924-0091-01
  • Packager: Acme United Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 12, 2024

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Acetaminophen 325 mg
    Chlorpheniramine Maleate 2 mg
    Phenylephrine Hydrochloride 5 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reduecer
    Antihistamine
    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    temporarily relieves these symptoms of hay fever or other upper respiratory allergies

    • nasal congestion
    • headache
    • itchy, watery eyes
    • itching of the nose and throat
    • running nose and sneezing
    • minor aches and pains
    • sinus congestion and pressure

  • WARNINGS

    Warnings

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

    ■ more than 4,000 mg of acetaminophen 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

    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.

    ■ for more than 10 days for pain unless directed by a doctor

    ■ for more than 3 days for fever unless directed by a doctor

    ■ with any other drug using the above active ingredients

    ■ 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 DOCTOR

    Ask a doctor before use if you have

    ■ liver disease

    ■ thyroid disease

    ■ diabetes

    ■ high blood pressure

    ■ heart disease

    ■ glaucoma

    ■ chronic bronchitis or emphysema

    ■ difficulty in urination due to enlargement of the prostate gland

  • WHEN USING

    When using this product

    ■ drowsiness may occur

    ■ avoid alcoholic beverages

    ■ alcohol, sedatives and tranquilizers may increase the drowsiness effect

    ■ use caution when driving a motor vehicle or operating machinery

    ■ excitability may occur, especially in children

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    ■ taking the blood thinning drug warfarin

    ■ taking sedatives or tranquilizers

  • STOP USE

    Stop use and ask a doctor if

    ■ symptoms do not improve within 7 days or are accompanied by a fever

    ■ pain or fever persists or gets worse

    ■ any new symptoms appear

    ■ redness or swelling is present

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not use more than directed


    Adults and children: (12 years and older)

    Take 2 tablets every 4 hours. Do not take more than 12 tablets in 24 hours.

    Children under 12 years:

    Do not give to children under 12 years of age.

  • INFORMATION FOR PATIENTS

    Other information

    • store at room temperature 59º-86ºF (15º-30ºC)
    • avoid excessive heat and humidity
    • tamper-evident sealed packets
    • do not use any opened or torn packets
  • INACTIVE INGREDIENT

    Inactive ingredients

    corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid


  • Questions?

    1-800-835-2263

  • Allergy Plus Label

    90091

    Physicians Care®

    Allergy Plus

    Multi-Symptom Relief

    Pull To Open

    This Package For Households Without Young Children.

    COATED TABLETS

    Tamper-Evident Packets of 2 Tablets

    Do not use if packet is open or torn.

    100 Tablets (50 Packets, 2 tablets each)

    PC

  • INGREDIENTS AND APPEARANCE
    PHYSICIANSCARE ALLERGY  MULTI-SYMPTOM RELIEF
    acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0091
    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
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AZ;275
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0091-0150 in 1 CARTON12/23/2011
    1NDC:0924-0091-002 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/23/2011
    Labeler - Acme United Corporation (001180207)