EXTRA STRENGTH NO-PAIN (ACETAMINOPHEN) TABLET [SAFREL PHARMACEUTICALS, LLC.]

EXTRA STRENGTH NO-PAIN (ACETAMINOPHEN) TABLET [SAFREL PHARMACEUTICALS, LLC.]
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NDC 71309-001-05, 71309-001-40
Set ID 873f01dd-0701-5fd3-e053-2a95a90a6463
Category HUMAN OTC DRUG LABEL
Packager Safrel Pharmaceuticals, LLC.
Generic Name
Product Class
Product Number
Application Number PART343
  • Active Ingredient

    (in each tablet)

    Acetaminophen 500mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporary relieves minor aches and pains due to
    • the common cold
    • headache
    • backache
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps and
    • temporarily reduces fever
  • Warnings

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

    • more than 4,000 mg 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 have ever had an allergic reaction to this product or any of its ingredients

    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.

  • If pregnant or breast-feeding

    ask a health professional before use

  • Keep out of reach of children.

    Overdose warning: Taking more than the reccomended dose (overdose) may cause liver damage. 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.
    Do not exceed recommended dosage.

  • Directions

    •  do not use more than directed (see overdose warning)
    • Adults and children 12 years of age and older:
    • Take 2 caplets every 6 hours while symptoms last.
    • Do not take more than 6 caplets in 24 hours, unless directed by a doctor
    • Do not use more than 10 days unless directed by a doctor.
    • Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.
  • Other Information

    • store at controlled room temperature 20-25°C (68-77°F).
    • read all product information before using.
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
  • Inactive Ingredients

    Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Polyethylene Glycol, Polyvinyl Pyrolidone, Stearic Acid, Talc, Titanium Dioxide

  • Questions or Comments

    1-844-384-3723 (Mon-Fri 9AM-5PM EST) or www.safrelpharma.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

    NDC 71309-001-40 40 Caplets

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH NO-PAIN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71309-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code BH
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71309-001-05500 in 1 BOTTLE; Type 0: Not a Combination Product07/31/2017
    2NDC:71309-001-401 in 1 CARTON07/31/2017
    240 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/31/2017
    Labeler - Safrel Pharmaceuticals, LLC. (080566287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceutical Ltd.915664486manufacture(71309-001)

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