Label: SINUS AND HEADACHE DAY NIGHT- acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride kit

  • 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 November 12, 2021

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

  • SPL UNCLASSIFIED SECTION

    SINUS + HEADACHE DAY

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each day caplet)  Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Phenylephrine HCl 5 mgNasal decongestant

  • Uses

    ■ temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
       ■ headache
       ■ sinus congestion and pressure
       ■ nasal congestion
       ■ minor aches and pains
    ■ helps decongest sinus openings and passages
    ■ promotes sinus drainage
    ■ helps clear nasal passages
    ■ temporarily reduces fever   

  • SPL UNCLASSIFIED SECTION

    SINUS + HEADACHE NIGHT

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each night caplet)Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Chlorpheniramine maleate 2 mgAntihistamine
    Phenylephrine HCl 5 mgNasal decongestant

  • Uses

    ■ temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
       ■ headache
       ■ sinus congestion and pressure
       ■ nasal congestion
       ■ runny nose and sneezing
       ■ minor aches and pains
    ■ helps decongest sinus openings and passages
    ■ promotes sinus drainage
    ■ helps clear nasal passages
    ■ temporarily reduces fever

  • Warnings

    Liver warning

    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

    ■ 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 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
    ■ a breathing problem such as emphysema or chronic bronchitis
    ■ glaucoma

    Ask a doctor or pharmacist before use if you are

    ■ taking the blood thinning drug warfarin
    ■ taking sedatives or tranquilizers

    When using this product

    do not exceed recommended dosage
    In addition, when using Sinus + Headache Night:
    ■ excitability may occur, especially in children
    ■ drowsiness may occur
    ■ alcohol, sedatives, and tranquilizers may increase drowsiness
    ■ avoid alcoholic drinks
    ■ be careful when driving a motor vehicle or operating machinery

    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
    These could be signs of a serious condition.

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

    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)

    ■ do not take Day and Night caplets at the same time
    ■ do not take more than a total of 10 caplets in 24 hours

    adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole; do not crush, chew, or dissolve
    children under 12 years
    • ask a doctor

  • Other information

    ■ store between 20-25ºC (68-77ºF) in a dry place
    ■ retain carton for complete product information and warnings

  • Inactive ingredients

    SINUS + HEADACHE DAY

    acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

    SINUS + HEADACHE NIGHT

    acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, flavor, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    GOOD NEIGHBOR PHARMACY®

    NDC 46122-661-60

    For Adults

    Day & Night

    Sinus + Headache

    acetaminophen, phenylephrine hcl, chlorpheniramine maleate*

    pain reliever/fever reducer, nasal decongestant, antihistamine*

    *Antihistamine in Nighttime only

    Day (Non-Drowsy)

    • Sinus Headache

    • Sinus Pressure

    • Nasal Congestion

    COOL TASTE

    12 CAPLETS

    Actual Size

    Night

    • Sinus Headache

    • Sinus Pressure

    • Nasal Congestion

    • Runny Nose*

    COOL TASTE

    8 CAPLETS

    Actual Size

    image description

  • INGREDIENTS AND APPEARANCE
    SINUS AND HEADACHE DAY NIGHT 
    acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-661
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-661-601 in 1 CARTON08/01/202008/31/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 12 
    Part 21 BLISTER PACK
    Part 1 of 2
    ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE 
    acetaminophen, and phenylephrine hydrochloride tablet, coated
    Product Information
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVAL (capsule-shaped) Size17mm
    FlavorMINTImprint Code AAA;1123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart341
    Part 2 of 2
    ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE 
    acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride tablet, coated
    Product Information
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (Off-White) Scoreno score
    ShapeOVAL (capsule-shaped) Size17mm
    FlavorMINTImprint Code AAA;1128
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart341
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/202008/31/2022
    Labeler - AMERISOURCE BERGEN (007914906)