Label: ACETAMINOPHEN EXTRA STRENGTH, 8 SINGLE USE VIALS X 30ML EA, ADULT USE- acetaminophen 1000mg/30ml solution

  • NDC Code(s): 70302-069-08
  • Packager: New Vision Pharmaceuticals LLC
  • 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 December 28, 2021

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

  • Active Ingredient Section

    Active Ingredient (in each Singel Use vial, 30mL)

    Acetaminophen USP, 1000mg

  • Purpose

    Pain reliever / fever reducer

  • Uses

    Temporarily relieves minor aches and pains due to:
    ■ the common cold ■ backache ■ toothache ■ headache ■ minor pain of arthritis
    ■ 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 4 (120mL) single-use vials (4,000mg) in 24 hours. ■ with other drugs containing
    acetamintophen. ■ 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 active 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 last more than 10 days
    ■ fever gets worse or last 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.

  • Directions

    ■ do not take more than directed (see overdose warning).
    ■ do not take more than 3 single-use vials in a 24-hour period.
    ■ empty each Single-Use Vial of all liquid when dosing.
    ■ do not take for more than 10 days unless directed by a doctor.
    ■ use the chart below to confirm dose.

    Dosing Chart

    Age (years)Dose (mL)
    Children under 12 yearsTalk to a doctor
    Adults and Children 12 years and over1 Single -Use vial (30mL) every 6 hours while symptoms last. Do not exceed 3 Single - Use Vials in 24 hours

  • Other Information

    ■ each Single-Use Vial contains 30mg of sodium.
    ■ store at 20-25ºC (68-77ºF).
    ■ tamper evident: do not use if top flap of carton
    is open. Do not use if any vials are open or broken.

  • Inactive Ingredients

    citric acid, cherry flavor, edetate disodium, glycerin, maltitol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum.

  • Questions or Comments?

    +1-800-609-04-09 Mon - Fri 9am to 6pm EST

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • OVERDOSE WARNING:

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

  • Principal Display Panel

    Package

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN EXTRA STRENGTH, 8 SINGLE USE VIALS X 30ML EA, ADULT USE 
    acetaminophen 1000mg/30ml solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70302-069
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN3.333 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MALTITOL (UNII: D65DG142WK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70302-069-088 in 1 CARTON05/20/2020
    130 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34305/20/202006/03/2022
    Labeler - New Vision Pharmaceuticals LLC (117900417)
    Establishment
    NameAddressID/FEIBusiness Operations
    New Vision Pharmaceuticals LLC117900417manufacture(70302-069) , label(70302-069) , pack(70302-069) , analysis(70302-069)