Label: ACETAMINOPHEN liquid
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Updated October 26, 2011
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- SPL UNCLASSIFIED SECTION
- Active ingredient Purpose (in each 5 mL = 1 teaspoon)
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 before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.
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.
This product does not contain directions or complete warnings for adult use.
- shake well before using
- if needed, repeat dose every 4 hours
- do not use more than 5 times in 24 hours
when weight is known: use the rotating bottle label to find the child's weight and read the correct dose. This is the most accurate dose.
when weight is unknown: use the age chart on the rotating label.
- use only enclosed dosing syringe and adapter to dose this product. Do not use any other dosing device
Age (yr) Dose (mL or tsp) under 6 mos. ask a doctor 6 mos. to under 2 2.5 mL or ½ tsp. 2 to under 4 5 mL or 1 tsp. 4 to under 6 7.5 mL or 1½ tsp. 6 to under 9 10 mL or 2 tsp. 9 to under 11 12.5 mL or 2½ tsp. 11 to under 12 15 mL or 3 tsp. or as directed by a doctor tsp. = teaspoon mL = milliliter
- ASK DOCTOR
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
Pain Reliever / Fever Reducer
For ages 6 mos. to
under 12 or 12-95 lbs.
Alcohol Free • Aspirin Free • Ibuprofen Free
Compares to the active
ingredient in Children's
Tylenol® Oral Solution.
4 FL. OZ. (120 mL)
80 mg per 1/2 teaspoon
(160 mg per 5 mL)
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45014-130 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D) Acetaminophen 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) Sorbitol (UNII: 506T60A25R) Sodium Benzoate (UNII: OJ245FE5EU) Anhydrous citric acid (UNII: XF417D3PSL) FD&C Red no. 40 (UNII: WZB9127XOA) Water (UNII: 059QF0KO0R) saccharin sodium (UNII: SB8ZUX40TY) Propylene glycol (UNII: 6DC9Q167V3) Prunus Serotina Bark (UNII: 5D48E975HA) POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45014-130-04 120 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part343 10/01/2011 Labeler - Accudial Pharmaceutical, Inc. (831999201)