PAIN RELIEF DYE FREE INFANTS (ACETAMINOPHEN) SUSPENSION [SAFEWAY, INC.]

PAIN RELIEF DYE FREE INFANTS (ACETAMINOPHEN) SUSPENSION [SAFEWAY, INC.]
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NDC 21130-323-02
Set ID b2639d24-2cf4-44d1-93e8-e3ccf82fe8e2
Category HUMAN OTC DRUG LABEL
Packager Safeway, Inc.
Generic Name
Product Class
Product Number
Application Number PART343
  • Active ingredient (in each 5 mL)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily reduces fever
    • temporarily relieves minor aches and pains due to:
      • the common cold
      • flu
      • headache
      • sore throat
      • toothache
  • Warnings

    Liver warning: This product contains acetamnophen. Severe liver damage may occur if your child takes:

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddenings
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

    Ask a doctor before use if your child has

    liver disease.

    Ask a doctor or pharmacist before use if your child is

    taking the blood thinning drug warfarin.

    When using this product,

    do not exceed recommended dose (see overdose warning)

    Stop use and ask a doctor if

    • new symptoms occur
    • redness or swelling is present
    • pain gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days

    These could be signs of a serious condition.

    Keep out of reach of children.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

  • Directions

    • this product does not contain directions or complete warnings for adult use.
    • do not take more than directed (see overdose warning)
    • shake well before using
    • mL=milliliter
    • find the right dose on chart below. If possible, use weight to dose; otherwise, use age
    • only use the enclosd syringe.

    Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.

    • remove cap and insert syringe into hole at top of bottle until it snap into place and turn upside down.
    • pull back syringe until filled to the prescribed level. if you pass the prescribed level,Invert assembly to right side up on a flat surface and simply push syringe back until you have reached the desired level.Slowly dispense the liquid into your child's mouth (towards inner cheek).
    • if needed, repeat dose every 4 hours while symptoms last.
    • do not use give more than 5 times in 24 hours
    • do not give more than 5 days unless directed by a doctor
    • replace cap tightly to maintain child resistance
    • find the right dose on chart below. If possible, use weight to dose; otherwise, use agw
    Weight (lb)Age (yr) Dose (mL)*
    under 24under 2 yearsask a doctor
    24-35 2-3 years

    5 mL

    *or as directed by a doctor

  • Other information

    • store between 20-25ºC (68-77ºF)
    • do not refrigerate.
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    butylparaben, carboxymethylcellulose sodium, citric acid, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • Questions or comments?

    Call 1-888-723-3929  Monday-Friday 7AM-6PM PST

  • Principal Display Panel

    DYE FREE InfantsPain Relief

    Acetaminophen

    160 mg per 5 mL

    Oral Suspension 

    Pain Reliever & Fever Reducer

    • Alcohol free
    • Aspirin free
    • Ibuprofen free
    • Medicine syringe included

    Compare to Infants' Tylenol® Oral Suspension active ingredient**

    Ages 2-3

    FL OZ (mL)

    Grape flavor

    **This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Infants' Tylenol® Oral Suspension.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR PRINTED SAFETY SEAL AROUND THE BOTTLE IS BROKEN OR MISSING.

    USE ONLY WITH ENCLOSED SYRINGE

    DISTRIBUTED BY

    BETTER LIVING BRANDS LLC

    P.O. BOX 99,PLEASANTON, CA 94566-0009

    www.betterlivingbrandsLLC.com

  • Package Label

    Acetaminophen 160 mg

    Signature Care Dye Free Infants Pain Relief

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  DYE FREE INFANTS
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-323
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-323-021 in 1 BOX06/30/201512/30/2021
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34306/30/201512/30/2021
    Labeler - Safeway, Inc. (009137209)

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