Label: PAIN AND FEVER- acetaminophen tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

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 January 18, 2020

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  • SPL UNCLASSIFIED SECTION

    SAVE CARTON FOR COMPLETE DRUG FACTS

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each chewable tablet)

    Acetaminophen 80 mg

  • PURPOSE

    Purposes

    Pain Reliever/Fever Reducer

  • INDICATIONS & USAGE

    Uses

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

  • WARNINGS

    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 other drug containing acetaminophen (prescription or non prescription). 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 dose (see overdose warning).

    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: In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800- 222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • this product does not contain directions or warnings for adult use.
    • find right dose on chart below. If possible, use weight to dose; otherwise use age.
    • chew before swallowing
    • if needed, repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    • do not give more than 5 days unless directed by a doctor
    WeightAgeDosage
    Under 24 lbsUnder 2 yearsAsk a doctor
    24-35 lbs2-3 years2 tablets
    36-47 lbs4-5 years3 tablets
    48-59 lbs6-8 years4 tablets
    60-71 lbs9-10 years5 tablets
    72-95 lbs11 years6 tablets

  • STORAGE AND HANDLING

    Other information

    • Phenylketonurics: Contains Phenylalanine 14 mg per tablet
    • Store at room temperature in a dry place
  • INACTIVE INGREDIENT

    Inactive ingredients Aspartame, Colloidal Silicon Dioxide, D&C Red #27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural and Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.

  • QUESTIONS

    Questions or comments?

    Call 1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    Distributed by: Rugby Laboratories

    17177 N. Laurel Park Drive, Suite 233

    Livonia, MI 48152

    www.rugbylaboratories.com

    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • HOW SUPPLIED

    Product: 50090-3463

    NDC: 50090-3463-0 30 TABLET, CHEWABLE in a BOTTLE, PLASTIC / 1 in a CARTON

  • Acetaminophen

    Label Image
  • INGREDIENTS AND APPEARANCE
    PAIN AND FEVER 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-3463(NDC:0536-1014)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUND (ROUND BICONVEX TABLET) Size10mm
    FlavorBERRY (Natural and Artificial) Imprint Code 1G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-3463-01 in 1 CARTON05/24/2018
    130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/01/2013
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-3463)
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