PAIN RELIEF ES (ACETAMINOPHEN) TABLET [AMERICAN SALES COMPANY]

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PAIN RELIEF ES (ACETAMINOPHEN) TABLET [AMERICAN SALES COMPANY]
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NDC 41520-012-24
Set ID 92e168fe-aa61-49a5-8aa0-2bf749c96a90
Category HUMAN OTC DRUG LABEL
Packager American Sales Company
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredient (in each caplet)

     Acetaminophen 500mg

  • Purpose

    Pain reliever/fever reducer

  • 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
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take   ■ more than 4000mg 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 other inactive ingredients in this product

    Ask a doctor before use if you have

    liver disease

    Ask a doctor or pharmacist before use if you are

    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,

    ask a professional before use.

    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.

  • Directions

    • do not take more than directed (see overdose warning)
    •  Adults and children 12 years and over: take 2 caplets every 6 hours whily 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: ask a doctor
  • Other information

    ■ store between 20º-25ºC (68º-77ºF)

    ■ do not use if imprinted safety seal under cap is broken or missing

  • Inactive ingredients

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

  • Principal Display Panel

    Pain Relief ES Carton

    Pain Relief ES Carton

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  ES
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code AZ012
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-012-241 in 1 CARTON06/10/2014
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34306/10/2014
    Labeler - American Sales Company (809183973)
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