Label: UNISHIELD BACK PAIN OFF- acetaminophen, caffeine, magnesium salicylate tablet, film coated

  • 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 July 8, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Acetaminophen 250 mg

    Caffeine 50 mg

    Magnesium Salicylate (NSAID*) 290 mg

    magnesium (total) 20 mg

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

    Pain reliever aid

    Analgesic

  • INDICATIONS & USAGE

    Uses

    temporarily relieves minor aches and pains associated with:
    ■ back pain ■ muscular aches

  • WARNINGS

    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 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount

    ■ 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

    Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

  • DO NOT USE

    Do not use

    ■ if you ever have had an allergic reaction to acetaminophen, salicylates (NSAIDs) or any other pain
    relievers/ fever reducers

    ■ 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 more than 10 days unless directed by a doctor

  • ASK DOCTOR

    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 DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    ■ taking prescription drugs for gout, diabetes, or arthritis

    ■ taking the blood thinning drug warfarin

    ■ under a doctor’s care for any serious condition

    ■ taking any other drug

  • WHEN USING

    When using this product do not exceed recommended dose

  • STOP USE

    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

    ■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

  • PREGNANCY OR BREAST FEEDING

    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

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    do not use more than directed

    ■ drink a full glass of water with each dose

    Adults and children: (12 years and older)

    Take 2 tablets with water every 6 hours while symptoms persist. Do not exceed 8 tablets in 24 hours or as directed by a doctor.

    Children under 12 years: Ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    ■ each dose contains 40 mg of magnesium

    ■ read all product information before using

    ■ store at room temperature 59º-86ºF (15º-30ºC)

    ■ avoid excessive heat and humidity

    ■ tamper evident sealed packets

    ■ do not use any opened or torn packets

  • INACTIVE INGREDIENT

    Inactive ingredients

    hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide

  • QUESTIONS

    Questions or comments? 800-480-5855

  • Unishield Back Pain-Off

    Unishield

    Back Pain-Off

    Back Pain Relief

    100 Tablets/2Tablets Per Packet

    Acetaminophen 250 mg

    Caffeine 50 mg

    Magnesium Salicylate (NSAID) 290 mg

    Pull To Open

    This Package is for Households Without Young Children.

    • Relieves backaches, muscular aches & Pains

    Extra Strength Pasin Relief

    Fast Acting Advanced Formula

    Tamper Evident Unit Dose Packets

    073R

  • INGREDIENTS AND APPEARANCE
    UNISHIELD BACK PAIN OFF 
    acetaminophen, caffeine, magnesium salicylate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-0733(NDC:47682-073)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE290 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE50 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-0733-350 in 1 BOX03/01/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/01/2021
    Labeler - Unishield (790677053)
    Registrant - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761repack(49314-0733)