BC SINUS CONGESTION AND PAIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [MEDTECH PRODUCTS INC.]

BC SINUS CONGESTION AND PAIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [MEDTECH PRODUCTS INC.]
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NDC 63029-221-04, 63029-221-12
Set ID b0e5db7f-fc7a-45cd-8407-b9e8a47be8cb
Category HUMAN OTC DRUG LABEL
Packager Medtech Products Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts                              

  • Active ingredients (in each powder)

    Acetaminophen 650 mg
    Chlorpheniramine maleate 4mg
    Phenylephrine hydrochloride 10mg

  • Purposes

    Pain reliever/Fever reducer
    Antihistamine
    Nasal decongestant

  • Uses

    • temporarily relieves these allergy and cold symptoms:
      • sinus congestion and pressure
      • headache
      • nasal congestion 
      • runny nose
      • sneezing
      • minor anches and pains
    • temporarily reduces fever
  • Warnings

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

    • more than 4,000 mg 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 (MOAI) (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.

    Ask a doctor before use if you have

    • liver disease
    • high blood pressure
    • diabetes
    • thyroid disease
    • glaucoma
    • heart disease
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are taking

    • the blood thinning drug warfarin
    • sedatives or tranquilizers

    When using this product

    • do not exceed recommended dosage
    • drowsiness may occur
    • avoid alcoholic drinks
    • excitability may occur, especially in children
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives and tranquilizers may increase the drowsiness effect

    Stop use and ask a doctor if

    • pain or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • you get nervous, dizzy, or sleepless
    • 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: Taking more than the recommended dose can cause serious health problems. In the 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 take more than directed (see overdose warning)
    • adults and children 12 years of age and over: place 1 powder on tongue every 4-6 hours, while symptoms persist.
    • do not take more than 6 powders in 24 hours unless directed by a doctor.
    • children under 12 years of age: ask a doctor.
  • Other information

    Store below 25°C (77°F)

  • Inactive ingredients

    magnesium stearate, maltodextrin, silica

  • Questions?

    1-866-255-5197 bcpowder.com

    TAMPER EVIDENT: DO NOT USE IF PACKET IS DAMAGED OR OPEN.

  • PRINCIPAL DISPLAY PANEL

    BC™  Sinus Pain & Congestion

    Acetaminophen       Pain Reliever / Fever Reducer
    Chlorpheniramine       Maleate Antihistamine
    Phenylephrine HCl       Nasal Decongestant

    12 Powders

    PRINCIPAL DISPLAY PANEL

BC™  Sinus Pain & Congestion 

Acetaminophen  	Pain Reliever / Fever Reducer
Chlorpheniramine 	Maleate  Antihistamine
Phenylephrine HCl  	Nasal Decongestant

12 Powders

  • INGREDIENTS AND APPEARANCE
    BC  SINUS CONGESTION AND PAIN
    acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-221
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-221-044 in 1 CARTRIDGE; Type 0: Not a Combination Product03/01/2016
    2NDC:63029-221-1212 in 1 CARTON; Type 0: Not a Combination Product03/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/01/2016
    Labeler - Medtech Products Inc. (122715688)

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