Label: OTIS CLAPP BACK QUELL- magnesium salicylate, acetaminophen tablet, film coated

  • NDC Code(s): 47682-587-03, 47682-587-99
  • Packager: Unifirst First Aid Corporation
  • 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 April 22, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredients (in each tablet)

    Acetaminophen 200 mg

    Magnesium Salicylate U.S.P. (NSAID*) 200 mg

    magnesium (total) 13 mg

    *nonsteroidal anti-inflammatory drug

    Close
  • Purposes

    Pain reliever/fever reducer

    Pain reliever/fever reducer

    Close
  • Uses

    For the temporary relief of minor aches and pains associated with

    • back pain
    • muscular aches
    Close
  • Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert:

    Salicylates (NSAIDs) may cause a severe allergic reaction which may include:

    ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    ■ skin reddening ■ blisters ■ rash

    If a skin or allergic reaction occurs, stop use and seek medical help right away.

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4,0000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    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.
    • for pain for more than 10 days unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor
    • if you ever have had an allergic reaction to any other pain relievers/ fever reducers
    • right before or after heart surgery
    • if you are taking prescription drugs for gout, diabetes, or arthritis

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have a history of stomach problems such as heartburn

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • under a doctor's care for any serious condition
    • taking any other drug

    When using this product

    • take with food or milk if stomach upset occurs

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • symptoms do not improve
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • ringing in the ears or loss of hearing occurs
    • redness or swelling is present in the painful area
    • any new symptoms appears

    If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use salicylates (NSAIDs) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Close
  • Directions

    • do not use more than directed

    Adults and children: (12 years and older)

    Take 2 tablets as needed for pain every 6 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor.

    Children under 12 years: Do not give to children under 12 years of age.

    Close
  • Other information

    • each dose contains 26mg of Magnesium
    • tamper evident, do not use if packet is torn, cut or opened.
    • store at controlled room temperature 15º-30ºC (59º to 86ºF)
    • avoid excessive heat and humidity
    Close
  • Inactive ingredients

    FD&C Red #28, microcrystalline cellulose, povidone, starch, stearic acid

    Close
  • Questions or comments?

    1-800-634-7680

    Close
  • Principal Display Panel - OC Back Quell Label

    Otis Clapp

    Quality and Integrity Since 1840

    BACK QUELL ™

    Pain Reliever

    Back Pain Relief

    Muscles and Sprains

    See Warnings and Directions on Side Panel

    Acetaminophen 200 mg,

    Magnesium Salicylate (NSAID) 200 mg

    Tear Out Along Perforation To Dispense

    PROFESSIONAL HEALTHCARE

    300 Tablets (150 PACKETS OF 2)

    OC Back Quell Label

    Close
  • INGREDIENTS AND APPEARANCE
    OTIS CLAPP BACK QUELL 
    magnesium salicylate, acetaminophen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-587
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE 200 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color pink (pink) Score no score
    Shape ROUND (ROUND) Size 12mm
    Flavor Imprint Code FR;1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47682-587-03 150 in 1 BOX 12/30/2008
    1 NDC:47682-587-99 2 in 1 PACKET; 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 12/30/2008
    Labeler - Unifirst First Aid Corporation (832947092)
    Establishment
    Name Address ID/FEI Business Operations
    Prestige Packaging 170837962 relabel(47682-587) , repack(47682-587)
    Close