Label: SEVERE SINUS CONGESTION AND PAIN- acetaminophen, guaifenesin, phenylephrine tablet, coated

  • NDC Code(s): 83059-0029-1
  • Packager: Shield Pharmaceuticals Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 8, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each caplet)

    Acetaminophen 325 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer
    Expectorant
    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
    • sinus congestion and pressure
    • headache
    • nasal congestion
    • minor aches and pains
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • temporarily reduces fever

  • Warnings

    Liver warning:This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
    • more than 4,000 mg of acetaminophen in 24 hours
    • 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.
    • 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 DOCTOR

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that occurs with too much phlegm (mucus)

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin

  • WHEN USING

    When using this productdo not exceed recommended dose

  • STOP USE

    Stop use and ask a doctor if
    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion or cough 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
    • cough comes back or occurs with rash or headache that lasts
    These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    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

    do not take more than directed (see OVERDOSE WARNING)

    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 10 caplets in 24 hours
    children under 12 yearsask a doctor

  • Other information

    • store between 20-25° C (68-77° F)

  • Questions or comments?

    1-800-373-6981 (toll-free)

  • Inactive ingredients

    croscarmellose sodium, colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol , polyvinyl alcohol, povidone, purified water, starch, talc, titanium dioxide

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Shield Pharmaceuticals Corp.
    Hauppauge, NY 11788

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredients in Tylenol® Sinus Severe

    Severe Sinus Congestion & Pain

    Acetaminophen,
    Guaifenesin, Phenylephrine HCl

    Carton

    Severe Sinus Congestion Carton

  • INGREDIENTS AND APPEARANCE
    SEVERE SINUS CONGESTION AND PAIN 
    acetaminophen, guaifenesin, phenylephrine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83059-0029
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code SD8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83059-0029-11 in 1 CARTON04/08/2024
    112 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/08/2024
    Labeler - Shield Pharmaceuticals Corp (118724924)