Label: SOUND BODY EXTRA STRENGTH PAIN RELIEVER- acetaminophen 500 mg tablet

  • 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 November 15, 2017

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

  • Active ingredient (in each caplet)

    Acetaminophen 500mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    temporarily relieves minor aches and pains due to:

    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps temporarily reduces fever
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  • Warnings

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

    • more than 4,000mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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.

    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 you are allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if you have

    liver disease.

    Ask a doctor or pharmacist before use if

    the user is taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 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

    • You may report side effects to 1-888-952-0050

    If pregnant or breast-feeding.

    If pregnant or breast-feeding, ask a health professional before use. 

    Keep out of reach of children.

    Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

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  • Directions

    • do not take more than directed (see overdose warning)

    Adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last

    • do not take more than 8 caplets in 24 hours, unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor 

    Children under 12 years of age: ask a doctor

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  • Other information

    • store between 20º-25ºC (68º-77ºF)
    • do not use if imprinted safety seal under cap is broken or missing
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  • Inactive ingredients

    corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

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  • Questions or comments?

    1-888-952-0500

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  • Principal Display Panel

    SOUNDBODY™

    Compare to the Active Ingredient in Tylenol® Caplets*

    EXTRA STRENGTH

    See New Warnings Information

    Pain Reliever

    Acetaminophen 500mg

    Pain Reliever/Fever Reducer

    100 Caplets

    (pill image) Actual Size

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®.

    Distributed by:
    Allegiant Health
    Deer Park, NY 11729

    V#5003620 ITEM#FP0638

    LB1299
    R0617

    Pain Relief EX 100ct. Caplets

    Pain Relief EX 100ct. Caplets

    Pain Relief EX 100ct. Caplets

    Pain Relief EX 100ct. Caplets

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  • INGREDIENTS AND APPEARANCE
    SOUND BODY EXTRA STRENGTH PAIN RELIEVER 
    acetaminophen 500 mg tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-913
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 15mm
    Flavor Imprint Code AZ012
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69168-913-01 1 in 1 CARTON 12/17/2014
    1 100 in 1 BOTTLE; 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 12/17/2014
    Labeler - Allegiant Health (079501930)
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