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

  • NDC Code(s): 41520-270-24
  • Packager: American Sales Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2018

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  • Active ingredients (in each caplet)

    Acetaminophen 325mg
    Phenylephrine HCl 5mg

  • Purpose

    Pain reliever
    Nasal decongestant

  • Uses

    temporarily relieves:

    ■ nasal and sinus congestion 
    ■ minor aches and pains, headaches

  • Warnings

    Liver warning: ​This product contains acetaminophen. Severe liver damage may occur if you take   ■ more than 8 caplets 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

    ■ 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  ■ with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    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

     do not use more than directed.

    Stop use and ask a doctor if

    ■ redness or swelling is present   ■ new symptoms occur   ■ you get nervous, dizzy or sleepless   ■ pain gets worse or lasts more than 7 days   ■ fever gets worse or lasts more than 3 days   ■ You may report side effects to 1-888-952-0050

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

  • Directions

    ■ Adults and children 12 years of age and older: take 2 tablets every 4-6 hours
    ■ Do not take more than 8 tablets in 24 hours

    ■ Do not use in children under 12 years of age. This will provide more than the recommended dose (overdose) and could cause serious health problems

  • Other Information

    • store at room temperature in a dry place
    • do not use if blister package is torn
  • 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

    CareOne® 

    Compare to the active ingredient in Sudafed PE® PRESSURE + PAIN**

    SINUS PRESSURE + PAIN PE
    Pain Reliever - Acetaminophen 
    Nasal Decongestant - Phenylephrine HCl

    Max Strength

    Relieves:
    Sinus Pain & Headache
    Sinus Pressure
    Nasal & Sinus Congestion

    Does not contain pseudoephedrine

    NON-DROWSY

    24
    COATED CAPLETS*
    *Capsule - Shaped Tablets

    DISTRIBUTED BY FOODHOLD U.S.A., LLC
    LANDOVER, MD 20785  1-877-846-9949
    ©2016 S&S Brands, LLC
    Quality guaranteed or your money back

    LB0604
    R0316

    **This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark SUDAFED PE® PRESSURE + PAIN.

    Care One Sinus Pressure + Pain PE

    Care One Sinus Pressure + Pain PE

  • INGREDIENTS AND APPEARANCE
    SINUS HEADACHE PE NON- DROWSY  MAXIMUM STRENGTH
    acetaminophen and phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-270
    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)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code AZ270
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-270-2424 in 1 BLISTER PACK; Type 0: Not a Combination Product06/12/201407/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01306/12/201407/31/2024
    Labeler - American Sales Company (809183973)
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