PAIN AND FEVER (ACETAMINOPHEN) TABLET, CHEWABLE [A-S MEDICATION SOLUTIONS]

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PAIN AND FEVER (ACETAMINOPHEN) TABLET, CHEWABLE [A-S MEDICATION SOLUTIONS]
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NDC 50090-3463-0
Set ID 4cf5a720-be5c-464d-b117-faeb06e3b11e
Category HUMAN OTC DRUG LABEL
Packager A-S Medication Solutions
Generic Name
Product Class
Product Number
Application Number PART343
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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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