Label: PAIN AND FEVER- 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 January 7, 2019

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

  • SPL UNCLASSIFIED SECTION

    SAVE CARTON FOR COMPLETE DRUG FACTS

    Drug Facts

    Close
  • ACTIVE INGREDIENT

    Active ingredient (in each chewable tablet)

    Acetaminophen 80 mg

    Close
  • PURPOSE

    Purposes

    Pain Reliever/Fever Reducer

    Close
  • INDICATIONS & USAGE

    Uses

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

    Close
  • 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.

    Close
  • 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
    Weight Age Dosage
    Under 24 lbs Under 2 years Ask a doctor
    24-35 lbs 2-3 years 2 tablets
    36-47 lbs 4-5 years 3 tablets
    48-59 lbs 6-8 years 4 tablets
    60-71 lbs 9-10 years 5 tablets
    72-95 lbs 11 years 6 tablets

    Close
  • STORAGE AND HANDLING

    Other information

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

    Close
  • QUESTIONS

    Questions or comments?

    Call 1-800-645-2158

    Close
  • 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

    Close
  • PRINCIPAL DISPLAY PANEL

    Rugby®

    See New Warnings Information

    NDC 0536-1014-07

    RELIEVES CHILDREN'S

    Pain and Fever

    WITHOUT ASPIRIN

    Acetaminophen, 80 mg EACH

    NATURAL & ARTIFICIAL BERRY FLAVORS

    30 CHEWABLE TABLETS

    AGES 2-11

    Rugby 0536-1014-07

    Close
  • INGREDIENTS AND APPEARANCE
    PAIN AND FEVER 
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1014
    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
    ASPARTAME (UNII: Z0H242BBR1)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (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
    Color pink Score no score
    Shape ROUND (ROUND BICONVEX TABLET) Size 10mm
    Flavor BERRY (Natural and Artificial) Imprint Code 1G
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-1014-07 1 in 1 CARTON 12/01/2013 05/31/2021
    1 30 in 1 BOTTLE, PLASTIC; 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 12/01/2013 05/31/2021
    Labeler - RUGBY LABORATORIES (079246066)
    Registrant - Gemini Pharmaceuticals, Inc. (055942270)
    Establishment
    Name Address ID/FEI Business Operations
    Gemini Pharmaceuticals, Inc. 055942270 manufacture(0536-1014)
    Close