Label: ACETAMINOPHEN ORAL SOLUTION- acetaminophen 160mg/5ml solution

  • NDC Code(s): 73564-816-16
  • Packager: Aldama Pharmaceuticals, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 18, 2026

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

  • Active ingredient (in each 5 mL-teaspoonful)

    Acetaminophen 160mg

  • 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:

    • if adults 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
    • adult has 3 or more alcoholic drinks everyday while using the 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

    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 DOCTOR

    Ask a doctor before use if your childhas liver disease

  • ASK DOCTOR/PHARMACIST

    Ask a doctor before use if you have taking the blood thinning drug warfarin.

  • WHEN USING

    When using this product do not exceed recommended dose

  • STOP USE

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days in adults 5 days
    • 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.

  • Keep out of reach of children.

    In case of overdose, get medical help or conbtact a Poison Control Center right away.  Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms

  • If pregnant or breast-feeding

    ask a health professional before use

  • DOSAGE & ADMINISTRATION

    Directions

    • find dose in 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 give more than 5 doses in 24 hours

     Weight

    (lbs)

     Weight

    (lbs)

     Weight

    (lbs)

     Weight

    (lbs)

     Weight

    (lbs)

     Weight

    (lbs)

     Weight

    (lbs)

    Weight

    (lbs)

     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

    (7.5ml)

     2 tsp

    (10 ml)

     2 1/2 tsp

    (12.5ml)

     3 tsp

    (15 ml)

     4 tsp

    (20 ml)

  • OTHER SAFETY INFORMATION

    Other information

    • for institutional or pharmacy use only
    • store at room temperature between 15-30°C (59-86°F)
    • do not freezing
    • protect from light
    • TAMPER EVIDENT do not use if foil seal over bottle opening is torn, broken or missing
  • INACTIVE INGREDIENT

    Inactive Ingredient

    artificial and natural cherry flavor, citric acid, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

  • QUESTIONS

    Question or Comments?

    call 305-592-9216 or info@aldamapharm.com

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN ORAL SOLUTION 
    acetaminophen 160mg/5ml solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73564-816
    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
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POLYETHYLENE GLYCOL 350 (UNII: ZBR3T82M2V)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73564-816-161 in 1 BOX01/01/2026
    1473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/01/2026
    Labeler - Aldama Pharmaceuticals, Inc (119484030)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aldama Pharmaceuticals, Inc119484030manufacture(73564-816)