SINUS PLUS HEADACHE DAY AND NIGHT (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCO ASSOCIATES LLC]

SINUS PLUS HEADACHE DAY AND NIGHT (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCO ASSOCIATES LLC]
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NDC 36800-928-02
Set ID 9881226c-b7cc-4b6d-9c6b-acd4cf76024a
Category HUMAN OTC DRUG LABEL
Packager TopCo Associates LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    SINUS CONGESTION & PAIN DAY

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each day caplet)Purpose
    Acetaminophen 325 mgPain reliever
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

    • for the temporary relief of:
      • sinus congestion and pressure
      • headache
      • nasal congestion
      • minor aches and pains
    • helps decongest sinus openings and passages
    • promotes sinus drainage
    • helps clear nasal passages
  • SPL UNCLASSIFIED SECTION

    SINUS CONGESTION & PAIN NIGHT

    Drug Facts

  • ACTIVE INGREDIENT

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

    • for the temporary relief of:
      • headache
      • sinus congestion and pressure
      • nasal congestion
      • runny nose and sneezing
      • minor aches and pains
    • reduces swelling of nasal passages
    • helps decongest sinus openings and passages
  • Warnings

    Liver warning

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

    • more than 12 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

    • 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
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    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 Congestion & Pain 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 12 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 20º-25ºC (68º-77ºF) in a dry place
    • retain carton for complete product information
  • Inactive ingredients

    Sinus Congestion & Pain Day

    acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, FD&C blue #1, flavor, hypromellose, lactose anhydrous, magnesium stearate, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

    Sinus Congestion & Pain Night

    acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, flavor, hypromellose, iron oxide ochre, lactose anhydrous, magnesium stearate, povidone, pregelatinized starch, propylene glycol, stearic acid, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    NDC 36800-928-02

    For Adults

    TopCare® Health™

    Sinus + Headache Day + Night

    Pharmacists Recommend

    Daytime Non-Drowsy

    Pain Reliever/Fever Reducer - Acetaminophen

    Nasal Decongestant - Phenylephrine HCl

    Day Caplet Relieves:

    Sinus Headache

    Sinus Pressure

    Nasal Congestion

    12 Cool Taste Caplets

    Nighttime

    Pain Reliever/Fever Reducer - Acetaminophen

    Nasal Decongestant - Phenylephrine HCl

    Antihistamine* – Chlorpheniramine Maleate*

    Night Caplet Relieves:

    Sinus Headache

    Sinus Pressure

    Nasal Congestion

    Runny Nose*

    *Antihistamine in Nighttime Only

    8 Cool Taste Caplets

    image description

  • INGREDIENTS AND APPEARANCE
    SINUS PLUS HEADACHE DAY AND NIGHT 
    acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-928
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-928-021 in 1 CARTON08/30/201106/30/2022
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVAL (capsule-shaped) Size17mm
    FlavorMINTImprint Code AAA;1114
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (Off-White) Scoreno score
    ShapeOVAL (capsule-shaped) Size17mm
    FlavorMINTImprint Code AAA;1117
    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 finalpart34108/30/201106/30/2022
    Labeler - TopCo Associates LLC (006935977)

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