PAIN RELIEF CHILDRENS (ACETAMINOPHEN) TABLET, CHEWABLE [AMERISOURCE BERGEN]

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  • PAIN RELIEF CHILDRENS (ACETAMINOPHEN) TABLET, CHEWABLE [AMERISOURCE BERGEN]

PAIN RELIEF CHILDRENS (ACETAMINOPHEN) TABLET, CHEWABLE [AMERISOURCE BERGEN]
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NDC 46122-424-62
Set ID 9ea8bb1f-1924-4430-98bd-f2674d0da748
Category HUMAN OTC DRUG LABEL
Packager Amerisource Bergen
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredient (in each chewable tablet)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • sore throat
      • flu
      • toothache
      • the common cold
    • temporarily reduces fever
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen

    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.

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    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 your child is allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if your child has

    liver disease.

    Ask a doctor or pharmacist before use if your child is

    taking the blood thinning drug warfarin.

    When using this product

    do not exceed recommended dosage.

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    These could be signs of a serious condition.

    Keep out of reach of children.

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

  • Directions

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed
    • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • chew or crush tablets completely before swallowing; do not swallow tablets whole
    • repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    • do not give for more than 5 days unless directed by a doctor
    Weight (lb)Age (yr)Dose (chewable tablets)*
    Under 24Under 2Ask a doctor
    24-352-31 tablet
    36-474-51 1/2 tablets
    48-596-82 tablets
    60-719-102 1/2 tablets
    72-95113 tablets

    *or as directed by a doctor

  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • avoid high humidity
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    GOOD
    NEIGHBOR
    PHARMACY    ®

    Compare to Children's Tylenol® active ingredient**

    NDC 46122-424-62

    For Ages 2-11

    CHILDREN'S

    Pain Relief
    acetaminophen 160 mg
    chewable tablets

    Pain Reliever/Fever Reducer

    •aspirin free
    •ibuprofen free

    Bubblegum Flavor

    Chew or crush tablets completely before swallowing.
    Do not swallow tablets whole.

    24 Tablets | 160 mg Each

    Actual Size

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    **This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Children's Tylenol®.
    50844   REV1018A45008

    GOOD NEIGHBOR PHARMACY BRAND PRODUCTS
    SATISFACTION GUARANTEED

    Distributed by
    AmerisourceBergen
    1300 Morris Drive
    Chesterbrook, PA 19087
    Questions or Concerns?
    www.mygnp.com

    Good Neighbor 44-450

    Good Neighbor 44-450

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  CHILDRENS
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-424
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Product Characteristics
    ColorpinkScore2 pieces
    ShapeROUNDSize16mm
    FlavorBUBBLE GUMImprint Code 44;450
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-424-624 in 1 CARTON02/25/2005
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/25/2005
    Labeler - Amerisource Bergen (007914906)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(46122-424)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(46122-424)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(46122-424)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(46122-424)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(46122-424)
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