Label: PAIN AND FEVER RELIEF CHILDRENS STRENGTH- acetaminophen tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 13, 2018

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

  • Active ingredient (in each tablet)

    Acetaminophen 80 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

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

    • if your child is allergic to acetaminophen or any of the inactive ingredients in this product
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    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.

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  • 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 24 Under 2 Ask a doctor
    24-35 2-3 2
    36-47 4-5 3
    48-59 6-8 4
    60-71 9-10 5
    72-95 11 6

    *or as directed by a doctor

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  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • avoid high humidity
    • protect from light
    • see end flap for expiration date and lot number
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  • 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

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  • Questions or comments?

    call 1-800-957-7622

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  • Principal display panel

    RapiMed™
    Melts in Your Child's Mouth

    NDC 51208-001-30

    Children's Strength
    For Children Ages 2-6

    Pain &
    Fever Relief

    ACETAMINOPHEN
    -80 mg each

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

    30 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

    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

    50844    ORG111364301

    Scrips America 44-643

    Scrips America 44-643

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  • INGREDIENTS AND APPEARANCE
    PAIN AND FEVER RELIEF  CHILDRENS STRENGTH
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51208-001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    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)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 13mm
    Flavor CHERRY (Wild Cherry) Imprint Code 44;643
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51208-001-30 5 in 1 CARTON 03/18/2014 06/02/2020
    1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 03/18/2014 06/02/2020
    Labeler - ScripsAmerica (842014177)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(51208-001)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(51208-001)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(51208-001)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(51208-001)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(51208-001)
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