Label: NORTEMP - acetaminophen solution/ drops

  • NDC Code(s): 63162-518-30
  • Packager: Ballay Pharmaceuticals, Inc
  • 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 20, 2013

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

  • Drug Facts

    Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)


    Purpose: Fever reducer/pain reliever

  • Uses


    ■ reduces fever

    ■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headaches ■ sore throat  ■ toothaches

  • Warnings

    Liver warning:This product contains acetaminophen. 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

    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 nonprescription). 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 dosage. (see overdose warning)
  • Stop use and ask a doctor if

    ■ new symptoms occur
    ■ redness or swelling is present
    ■ pain gets worse or lasts for more than 5 days
    ■ fever gets worse or lasts for more than 3 days. These could be signs of 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 give more than directed (see overdose warning) ■ find right dose chart, if possible use weight to dose; otherwise, use age ■ use only enclosed dropper designed for use with this product, do not use any other dosing device ■ fill to dose level ■dispense liquid slowly into child's mouth, toward inner cheek ■ may be given alone or mixed with formula, milk, juice etc. ■if needed repeat dose every 4 hours ■do not give more than 5 times in 24 hours ■ Replace dropper tightly to maintain child resistance

    Weight (lb) Age (yr) Dose (mL)
    Under 24
    under 2 years
    Ask a Doctor
    2-3 years
    1.6 mL (0.8mL +0.8mL)

    For accurate dosing follow dosing instructions using the enclosed dropper. Fill dropper to 0.8 mL or prescribed level, and dispense with a single firm squeeze of the dropper bulb

    Other information
    Store between 20°-25°C (68°-77°F)

  • Inactive ingredients

    citric acid, FD&C yellow no. 6, cherry flavor, methylparaben, saccharin sodium, sodium benzoate, sodium citrate, propylene glycol and purified water.

  • Comments


    Manufactured for:

    BallayPharmaceuticals, Inc.
    200 Stillwater St.
    Wimberley , TX 78676

    acetaminophen solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63162-518
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 80 mg  in 0.8 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid (UNII: XF417D3PSL)  
    FD&C yellow no. 6 (UNII: H77VEI93A8)  
    methylparaben (UNII: A2I8C7HI9T)  
    saccharin sodium dihydrate (UNII: SB8ZUX40TY)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (wild cherry) Imprint Code
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63162-518-30 30 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/01/1997
    Labeler - Ballay Pharmaceuticals, Inc (035888200)