Label: CHILDRENS ACETAMINOPHEN ORAL SUSPENSION- acetaminophen suspension
- NDC Code(s): 0121-0966-00, 0121-0966-05, 0121-0966-94
- Packager: PAI Holdings, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 4, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses temporarily:
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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 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
- ASK DOCTOR
- WHEN USING
- Stop use and ask a doctor if:
- KEEP OUT OF REACH OF CHILDREN
- Overdose Warning:
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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
Attention: For Single-Dose Cups, the entire dose should be taken.
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
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Other information
- each 5 mL contains: sodium: 2 mg
- Store at 20° to 25°C (68° to 77°F)
- grape flavored suspension supplied in the following oral dosage form:
NDC 0121-0966-05: 5 mL unit dose cup, in a tray of ten cups.
NDC 0121-0966-94: Case contains 30 unit dose cups of 5 mL (0121-0966-05) packaged in 3 trays of 10 unit dose cups each.
NDC 0121-0966-00: Case contains 100 unit dose cups of 5 mL (0121-0966-05) packaged in 10 trays of 10 unit dose cups each. - INACTIVE INGREDIENT
- Questions or Comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
CHILDRENS ACETAMINOPHEN ORAL SUSPENSION
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-0966 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 MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) BUTYLPARABEN (UNII: 3QPI1U3FV8) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 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 appearance) Score Shape Size Flavor GRAPE (grape flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0121-0966-94 3 in 1 CASE 03/09/2022 1 10 in 1 TRAY 1 NDC:0121-0966-05 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:0121-0966-00 10 in 1 CASE 03/09/2022 2 10 in 1 TRAY 2 NDC:0121-0966-05 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 Drug M013 03/09/2022 Labeler - PAI Holdings, LLC (044940096) Establishment Name Address ID/FEI Business Operations PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma 097630693 label(0121-0966) , manufacture(0121-0966)