Label: CHILDREN ACETAMINOPHEN ORAL SOLUTION- acetaminophen liquid
- NDC Code(s): 0904-7014-16, 0904-7014-20
- Packager: MAJOR PHARMACEUTICALS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 9, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
WARNINGS
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
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.
Sore throat warning: if sore thoat 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 acetaminophe or any of the inactive indreadients in this product.
Ask a doctor before use if your child has liver disease.
Ask a doctor 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.
- INDICATIONS & USAGE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- do not take more than directed
- find dose in chart below
- if possible, use weight to dose, otherwise use age
- dosage may be repeasted 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 Age (years) under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 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) - INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHILDREN ACETAMINOPHEN ORAL SOLUTION
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-7014 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-7014-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2019 2 NDC:0904-7014-20 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 10/01/2019 Labeler - MAJOR PHARMACEUTICALS (191427277)
