Label: ACETAMINOPHEN SOLUTION- acetaminophen liquid
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NDC Code(s):
39328-031-05,
39328-031-50,
39328-031-99,
39328-032-10, view more39328-032-50, 39328-032-99, 39328-034-20, 39328-034-50, 39328-034-99
- Packager: Patrin Pharma, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 21, 2024
If you are a healthcare professional or from the pharmaceutical industry 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
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if:
- an adult takes more than 6 doses in 24 hours, or greater than 4000 mg of acetaminophen, the maximum daily amount
- a child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- taken with 3 or more alcoholic drinks every day while using this product
Allergy
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
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
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
- if you are allergic to acetaminophen or any of the inactive ingredients of his product
Stop use and ask a doctor if
- symptoms do not improve
- new symptoms occur
- pain or fever persists or gets worse
- redness or swelling is present
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 for adults as well as children even if you do not notice any signs or symptoms.
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Directions
- Do not take more than directed (see overdose warning)
- Use the following dosage guidelines when using this product
AGE DOSE Adults and children 12 years of age and over 20.3 mL (650 mg) every 4 to 6 hours
Not to exceed 6 doses in a 24-hour periodChildren 6 to under 12 years of age 10.15 mL (325 mg) every 4 hours
Not to exceed 5 doses in a 24-hour periodChildren 4 to under 6 years of age 7.5 mL (240 mg) every 4 hours
Not to exceed 5 doses in a 24-hour periodChildren 2 to under 4 years of age 5 mL (160 mg) every 4 hours
Not to exceed 5 doses in a 24-hour periodChildren under 2 years of age Consult a doctor - Other Information
- Inactive Ingredients
- Questions Or Comments?
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How Supplied
- A red, cherry flavored solution supplied in the following oral dosage cups:
NDC 39328-031-05: 5 mL unit dose cup NDC 39328-031-50: Case contains 50 unit dose cups of 5 mL (39328-031-05). NDC 39328-031-99: Case contains 100 unit dose cups of 5 mL (39328-031-05). NDC 39328-032-10: 10.15 mL unit dose cup NDC 39328-032-50: Case contains 50 unit dose cups of 10.15 mL (39328-032-10). NDC 39328-032-99: Case contains 100 unit dose cups of 10.15 mL (39328-032-10). NDC 39328-034-20: 20.3 mL unit dose cup NDC 39328-034-50: Case contains 50 unit dose cups of 20.3 mL (39328-034-20). NDC 39328-034-99: Case contains 100 unit dose cups of 20.3 mL (39328-034-20). - SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
- PRINCIPAL DISPLAY PANEL - 10.15 mL Cup Label
- PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN SOLUTION
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:39328-031 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) Glycerin (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) WATER (UNII: 059QF0KO0R) Saccharin sodium (UNII: SB8ZUX40TY) Sodium benzoate (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Sorbitol (UNII: 506T60A25R) 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:39328-031-50 5 in 1 CASE 09/27/2023 1 10 in 1 TRAY 1 NDC:39328-031-05 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:39328-031-99 10 in 1 CASE 05/13/2024 2 10 in 1 TRAY 2 NDC:39328-031-05 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 09/27/2023 ACETAMINOPHEN SOLUTION
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:39328-032 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) Acetaminophen 325 mg in 10.15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) Glycerin (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) WATER (UNII: 059QF0KO0R) Saccharin sodium (UNII: SB8ZUX40TY) Sodium benzoate (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Sorbitol (UNII: 506T60A25R) 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:39328-032-50 5 in 1 CASE 09/27/2023 1 10 in 1 TRAY 1 NDC:39328-032-10 10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:39328-032-99 10 in 1 CASE 05/13/2024 2 10 in 1 TRAY 2 NDC:39328-032-10 10.15 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 09/27/2023 ACETAMINOPHEN SOLUTION
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:39328-034 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) Acetaminophen 650 mg in 20.3 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) Glycerin (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) WATER (UNII: 059QF0KO0R) Saccharin sodium (UNII: SB8ZUX40TY) Sodium benzoate (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Sorbitol (UNII: 506T60A25R) 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:39328-034-50 5 in 1 CASE 10/16/2023 1 10 in 1 TRAY 1 NDC:39328-034-20 20.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:39328-034-99 10 in 1 CASE 05/13/2024 2 10 in 1 TRAY 2 NDC:39328-034-20 20.3 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 10/16/2023 Labeler - Patrin Pharma, Inc. (806841677)