PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [GERI-CARE PHARMACEUTICAL CORP]

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PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [GERI-CARE PHARMACEUTICAL CORP]
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NDC 57896-180-16
Set ID 6bc9fca3-0860-5363-e053-2991aa0a84d0
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredient (per teaspoonful = 5 mL)

    Acetaminophen 160 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.

    Severe liver damage may occur if

    • adult takes more than 6 doses in 24 hours, which is the maximum daily amount
    • child takes more than 5 doses in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adults has 3 or more alcoholic drinks everyday while using this product

    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 you are allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if the user

    • has a liver disease
    • is on a sodium restricted diet

    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

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 5 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 breastfeeding, ask a health professional before use.

    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. Quick medical attention is critical even if you do not notice any signs or symptoms.

  • Directions

    • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • dosage may be repeated every 4 hours, or as directed by a doctor
    • do not use more than 5 times in 24 hours
    Weight (lbs.)Age (yrs.)Dose (tsp or mL)
    under 24under 2consult physician
    24-352-31 tsp (5 mL)
    36-474-51½ tsp (7.5 mL)
    48-596-82 tsp (10 mL)
    60-719-102½ tsp (12.5 mL)
    72-95113 tsp or (15 mL)
    over 9512 to adult4 tsp (20 mL)
  • Other information

    • each teaspoon (5 mL) contains: sodium 7 mg
    • Store at room temperature 15º - 30ºC (59º - 86ºF)
    • Protect from Freezing.
    • Protect from Light.
    • for institutional use only
  • Inactive ingredients

    citric acid, FD&C red # 40, flavor, glycerin, PEG 400, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water.

  • PRINCIPAL DISPLAY PANEL

    180-16

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-180
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-180-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/201209/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/01/201209/30/2022
    Labeler - GERI-CARE PHARMACEUTICAL CORP (611196254)
    Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)
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