Label: ACETAMINOPHEN (RED) (acetaminophen- red - acetaminophen capsule liquid filled capsule, liquid filled

  • 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 February 22, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each capsule)

    Acetaminophen 325 mg

  • Purpose

    Pain reliever/ fever reducer

  • Uses

    • Temporarily relieves minor aches and pains due to :

         ◦ headache
         ◦ muscular aches
         ◦ backache
         ◦ minor pain of arthritis
         ◦ the common cold
         ◦ toothache
         ◦ premenstrual and menstrual cramps  

    • Temporarily reduces fever

  • Warnings

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if
    • adult takes more than 4,000 mg of acetaminophen in 24 hours
    • child takes more than 5 doses in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks every day while using this product

    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 DOCTOR

    Ask a doctor before use if the user has liver disease

  • ASK DOCTOR/PHARMACIST

    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 in adults
    • pain gets worse or lasts more than 5 days in children under 12 years
    • 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.

  • PREGNANCY 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 right away. (1-800-222-1222) 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
    (seeOverdose warning)

     adults and children 12 years and over
    • take 2 softgels every 4 to 6 hours while symptoms last
    • do not take more than 10 softgels in 24 hours
    • do not use for more than 10 days unless directed by a doctor
     children 6-11 years
    • take 1 softgel every 4 to 6 hours while symptoms last
    • do not take more than 5 softgels in 24 hours
    • do not use for more than 5 days unless directed by a doctor
     children under 6 years ask a doctor

  • Other Information

    store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

  • Inactive ingredients

    FD&C red #40, gelatin, sorbitol, glycerin, polyethylene glycol 400, povidone K-30, propylene glycol, titanium dioxide, purified water

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    ACETAMINOPHEN CAPSULES, 325 mg

    Quantity : 48 Bags of 300 Capsules each
    NDC. No : 55629-718-01

    Important:

    1. Inspect immediately upon receipt

    2. This is bulk shipment intended for further processing only
    3. Store at controlled temperature of 59°F to 86°F (15°C to 30°C) avoid high humidity and excessive heat above 104°F (40°C)

    PRINCIPAL DISPLAY PANEL - Shipping Label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN (RED) 
    acetaminophen (red) - acetaminophen capsule liquid filled capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55629-718
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE K30 (UNII: U725QWY32X)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScoreno score
    Shapecapsule (Oblong) Size20mm
    FlavorImprint Code 718
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55629-718-0148 in 1 BOX02/25/2019
    1NDC:55629-718-02300 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/25/2019
    Labeler - One2zee Limited Liability Company (078656111)
    Registrant - One2zee Limited Liability Company (078656111)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medgel Private Limited677385498manufacture(55629-718) , analysis(55629-718)
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