Label: MOORE MEDICAL SINUS PAIN AND PRESSURE RELIEF- acetaminophen, phenylephrine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL

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 6, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Acetaminophen 500 mg

    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer

    Nasal decongestant

  • Uses

    Temporarily relieves nasal congestion due to

    • common cold
    • hay fever or other respiratory allergies

    Temporarily

    • promotes nasal and/or sinus drainage; relieves sinus congestion and pressure
    • reduces fever

    Temporarily relieves minor aches and pains associated with

    • headache
    • muscular aches
    • minor arthritis pain
    • common cold
    • toothache
    • menstrual cramps
  • Warnings

    Liver warning:

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

    • more than 8 tablets 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.
    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor
    • 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
    • thyroid disease
    • diabetes
    • high blood pressure
    • heart disease
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin

    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
    • redness or swelling is present
    • any new symptoms appear

    Do not exceed recommended dosage. If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor.

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

    Keep out of 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.

  • Directions:

    • do not use more than directed

    Adults and children (12 years and older): Take 2 tablets every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.

    Children under 12 years: Do not give this adult strength product to children under 12 years
    of age; this will provide more than the recommended dose
    (overdose) and may cause liver damage

  • Other information

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

    corn starch, crospovidone*, FD&C blue #1*, hypromellose*, microcrystalline cellulose, polyethylene glycol*, povidone, sodium starch glycolate*, stearic acid.

    *may contain

  • Questions or comments?

    1.800.234.1464

  • Moore Medical Sinus Pain and Pressure Relief Label

    mooremedical

    Supporting Health & Care

    Reorder No. 82475

    UPN# 0-0607415-82475-9

    MooreBrand®

    Sinus Pain and Pressure Relief

    250 Packets/ 2 Tablets

    Acetaminophen 500mg., Phenylephrine HCl 5mg.

    Non-aspirin pain relief and
    Pseudoephedrine-free sinus decongestant

    To Reorder:

    Call: 1.800.234.1464

    Fax: 1.800.944.6667

    Online: www.mooremedical.com

    Moore Medical

  • INGREDIENTS AND APPEARANCE
    MOORE MEDICAL SINUS PAIN AND PRESSURE RELIEF 
    acetaminophen, phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55670-150
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorblue (blue) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code FR;33
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55670-150-13250 in 1 BOX12/30/200807/31/2024
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/30/200807/31/2024
    Labeler - Moore Medical LLC (051420107)
    Registrant - Unifirst First Aid Corporation (832947092)