Label: GERICARE LIQUID PAIN RELIEF- acetaminophen liquid

  • NDC Code(s): 57896-160-16
  • Packager: Geri-Care Pharmaceuticals, Corp
  • 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 March 15, 2021

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

  • ACTIVE INGREDIENT

    per 5 mL teaspoonful

    Acetaminophen - 160 mg

  • PURPOSE

    Purpose

    Pain Reliever

    Fever Reducer

  • INDICATIONS & USAGE

    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
  • WARNINGS

    Warnings

    Liver warning: This product contains acetaminophen. Severe liver damagemayoccurif: •adulttakesmorethan6dosesin24 hours,whichisthemaximumdailyamount •childtakesmore 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 everyday 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.

    Ask a doctor before use if you have a liver disease.

    Ask a doctor 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 10daysinadults •paingetsworseorlastsmorethan5daysin children under 12 years • fever gets worse or lasts more than 3 days •newsymptomsoccur •rednessorswellingispresent. 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. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than directed
    • find dose in chart below
    • if possible, use weight to dose, otherwise use age
    • doasge may be repeated every 4 hours, or as directed by a doctor
    • do not give more than 5 doses in 24 hours
     Weight (lbs) Under 24 24 - 35 36 - 47 48 - 59 60 - 71 72 - 95 Over 95
     Age (years) Under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 12 to adult
     Dosage Teaspoonful (tsp) consult physician 1 tsp (5 mL) 1 1/2 tsp (7.5 mL) 2 tsp (10 mL) 2 1/2 tsp (12.5 mL) 3 tsp (15 mL) 4 tsp (20 mL)

  • INACTIVE INGREDIENT

    Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

  • QUESTIONS

    DIST. BY: Geri-Care Pharmaceuticals Corp. 1650 63rd Street 3 Brooklyn, NY 11204

  • PRINCIPAL DISPLAY PANEL

    GeriAceta

  • INGREDIENTS AND APPEARANCE
    GERICARE LIQUID PAIN RELIEF 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-160
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-160-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34305/01/2019
    Labeler - Geri-Care Pharmaceuticals, Corp (611196254)