Label: CHILDRENS ACETAMINOPHEN suspension
- NDC Code(s): 0121-0946-00, 0121-0946-05, 0121-0946-30
- Packager: Pharmaceutical Associates, Inc.
- 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 May 26, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- Purpose
- Uses
-
WARNINGS
Liver warnings
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 acetaminophenAllergy 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 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 productAsk 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 the recommended dose (see overdose warning)
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. -
Directions
- this product does not contain directions or complete warnings for adult use
- do not take more than directed (see overdose warning)
- shake well before using
- mL = milliliter
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (mL)* Under 24 Under 2 years ask a doctor 24-35 2-3 years 5 mL 36-47 4-5 years 7.5 mL 48-59 6-8 years 10 mL 60-71 9-10 years 12.5 mL 72-95 11 years 15 mL *or as directed by a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
-
INGREDIENTS AND APPEARANCE
CHILDRENS ACETAMINOPHEN
childrens acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-0946 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 ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) BUTYLPARABEN (UNII: 3QPI1U3FV8) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL SOLUTION (UNII: 8KW3E207O2) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color white (to off-white) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0121-0946-30 3 in 1 CASE 09/07/2021 1 10 in 1 TRAY 1 NDC:0121-0946-05 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:0121-0946-00 10 in 1 CASE 09/07/2021 2 10 in 1 TRAY 2 NDC:0121-0946-05 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/07/2021 Labeler - Pharmaceutical Associates, Inc. (044940096) Establishment Name Address ID/FEI Business Operations Pharmaceutical Associates, Inc. 097630693 manufacture(0121-0946) , label(0121-0946)