Label: SINUS HEADACHE PEMAXIMUM STRENGTH NON-DROWSY MAXIMUM STRENGTH NON-DROWSY- acetaminophen and phenylephrine hcl tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2018

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  • Active ingredient (in each caplet)

    Acetaminophen 325 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer
    Nasal decongestant

  • Uses

    temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:  

    • sinus congestion and pressure
    • headache
    • minor aches and pains
    • nasal congestion
    • promotes sinus drainage
    • temporarily reduces fever
  • Warnings

    Liver warning/Allergy alert

    Liver warning: This product contains acetaminophen.

    Severe liver damage may occur if you take

    • more than 4,000mg of acetaminophen in 24 hours
    • with other drugs containing acetminophen
    • 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 using 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
    • trouble urinating due to an enlarged prostate

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

    When using this product

    When using this product do not exceed recommended dose

    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
    • You may report side effects to 1-888-952-0050

    If pregnant 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 use more than directed (see overdose warning)

    adults and children 12 years of age and older:

    • take 2 caplets every 4-6 hours
    • do not take more than 10 caplets in 24 hours  

    children under 12 years:

    • ask a doctor 
  • Inactive Ingredients

    corn starch, crospovidone, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

  • Package/Label Principal Display Panel

    Sinus Headache

    Sinus Headache

  • INGREDIENTS AND APPEARANCE
    SINUS HEADACHE PEMAXIMUM STRENGTH NON-DROWSY  MAXIMUM STRENGTH NON-DROWSY
    acetaminophen and phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-270
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code AZ270
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-270-9518 in 1 BLISTER PACK; Type 0: Not a Combination Product12/22/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01312/22/2014
    Labeler - Allegiant Health (079501930)
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