RUGBY ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY LABORATORIES]

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RUGBY ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY LABORATORIES]
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NDC 0536-1212-77
Set ID 175aca2f-a88b-4b2d-9806-984ed0e49ff7
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredient (in each 5 mL)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily:

    •
    reduces fever
    •
    relieves minor aches and pains due to:
    •
    the common cold
    •
    flu
    •
    headache
    •
    sore throat
    •
    toothache
  • 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 has ever had an allergic reaction to this product or any of its ingredients

    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 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.

  • Directions

    •
    this product does not contain directions or complete warnings for adult use
    •
    do not give more than directed (see overdose warning)
    •
    shake well before using
    •
    mL = milliliter
    •
    find right dose on chart. If possible, use weight to dose; otherwise, use age.
    •
    push air out of syringe. Insert syringe tip into bottle opening.
    •
    flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle.
    •
    pull yellow part of syringe until it reaches and stays at the correct dose
    •
    dispense liquid slowly into child’s mouth, toward inner cheek
    •
    repeat dose every 4 hours while symptoms last
    •
    do not give more than 5 times in 24 hours
    •
    replace cap tightly to maintain child resistance

    Dosing Chart

    Weight (lb)

    Age (yr)

    Dose (mL)*

    under 24

    under 2 years

    ask a doctor

    24-35

    2-3 years

    5 mL

    * or as directed by a doctor

    Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

  • Other information

    •
    store at 20-25°C (68-77°F)
    •
    do not use if printed neckband is broken or missing
  • Inactive ingredients

    anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, FD&C red #40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

  • Questions or comments?

    1-800-645-2158

  • Package/Label Principal Display Panel

    ASPIRIN & ALCOHOL FREE

    COMPARE TO THE ACTIVE INGREDIENT IN INFANTS’ TYLENOL® ORAL SUSPENSION

    INFANTS’

    Acetaminophen 160 mg per 5 mL

    Oral Suspension

    Pain Reliever/Fever Reducer

    Alcohol Free

    Aspirin Free

    Ibuprofen Free

    For Ages 2-3 Years

    Use only with enclosed syringe. See side panel for more information.

    CHERRY FLAVORED

    2 fl oz (59 mL)

    161-8t-acetaminophen.jpg
  • INGREDIENTS AND APPEARANCE
    RUGBY ACETAMINOPHEN 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1212
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CALCIUM SULFATE (UNII: WAT0DDB505)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1212-771 in 1 CARTON11/16/2018
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/16/2018
    Labeler - Rugby Laboratories (079246066)
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