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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 10, 2022

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
    CROSPOVIDONE (UNII: 2S7830E561)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    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 finalpart34112/23/2011
    Labeler - Acme United Corporation (001180207)