PAIN AND FEVER RELIEF JUNIOR STRENGTH (ACETAMINOPHEN) TABLET, CHEWABLE [SCRIPSAMERICA]

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PAIN AND FEVER RELIEF JUNIOR STRENGTH (ACETAMINOPHEN) TABLET, CHEWABLE [SCRIPSAMERICA]
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NDC 51208-003-24
Set ID d0a9bd82-d569-4b18-b0c3-0c5c8f6cba1f
Category HUMAN OTC DRUG LABEL
Packager ScripsAmerica
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredient (in each tablet)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

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

    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.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

  • Directions

    • do not give more than directed (see overdose warning)
    • this product does not contain directions or complete warnings for adult use
    • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • chew before swallowing; this product will soften in mouth for ease of chewing
    • 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 (tablets)*
    Under 48Under 6Ask a doctor
    48-596-82
    60-719-102 1/2
    72-95113

    *or as directed by a doctor

  • Other information

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

    citric acid, corn starch, 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?

    call 1-800-957-7622

  • Principal Display Panel

    RapiMed™
    Melts in Your Child's Mouth

    NDC 51208-003-24

    Junior Strength
    For Children Ages 6-11

    Pain &
    Fever Relief
    ACETAMINOPHEN     - 160 mg each

    • Pain Reliever/Fever Reducer
    • Contains no Aspirin
    • Melts in Your Child's Mouth

    24 Quick Dissolving Tablets

    WILD CHERRY FLAVOR

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

    50844    ORG111364408

    Manufactured
    in the United
    States of America

    Distributed by: Scrips America Inc.
    Tysons Corner, VA 22102
    Telephone: 1-800-596-4874
    Website: www.rapimeds.com
    Email: wecare@rapimeds.com

    Scrips America 44-644

    Scrips America 44-644

  • INGREDIENTS AND APPEARANCE
    PAIN AND FEVER RELIEF  JUNIOR STRENGTH
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51208-003
    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)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Product Characteristics
    ColorPINKScore2 pieces
    ShapeROUNDSize16mm
    FlavorCHERRYImprint Code 44;644
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51208-003-244 in 1 CARTON02/25/200501/15/2023
    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 FINALpart34302/25/200501/15/2023
    Labeler - ScripsAmerica (842014177)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(51208-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(51208-003)
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