Label: ACETAMINOPHEN solution
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NDC Code(s):
81033-002-05,
81033-002-10,
81033-002-20,
81033-002-30, view more81033-002-40, 81033-002-50, 81033-002-53, 81033-002-54, 81033-002-55
- Packager: Kesin Pharma Corporation
- This is a repackaged label.
- Source NDC Code(s): 84447-104
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 3, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACETAMINOPHEN Oral Solution 160mg per 5mL
- Active Ingredients (in each 5 mL)
- PURPOSE
- USES
-
WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than more than 6 doses in in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks everyday while using this product
Ask a doctor before use if the user has liver disease.
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 throat is severe, persistent for more than 2 days, or is accompanied or followed by a fever,
headache, nausea, rash, or vomiting, consult a physician 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 3 days for fever unless directed by a doctor
- for more that 10 days for pain unless directed by a doctor
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.
Stop use and ask a doctor if
Stop use and ask a doctor if
- symptoms do not improve
- new symptoms occur
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
These could be signs of a serious condition.
If Pregnant or breast-feedinging
If pregnant or breast-feeding, ask a health professional before use.
Overdose warning:
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 for children even if you do not notice any signs or symptoms. -
DIRECTIONS
- do not take more than directed (see overdose warning)
Age Dose
adults and children 12 years of age and over 20.3 mL (650 mg) every 4 to 6 hours not to excdeed 6 doses in a 24-hour period children 6 to Under 12 years of age 10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period children 4 to under 6 years of age 7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period children under 2 years of age consult a doctor -
OTHER INFORMATION
- store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
- keep tightly closed
- protect from light
- tamper evident: DO NOT use if foil on cup is missing or torn
- a clear, grape flavored solution supplied in the following oral dosage forms:
NDC 81033-002-05: 5 mL (160mg) unit dose cup
NDC 81033-002-55: Case contains 100 unit dose cups of 5 mL (81033-002-05); packaged in a carton of 50 unit dose cups each.
NDC 81033-002-10: 10.15mL (325mg) unit dose cup
NDC 81033-002-54: Case contains 100 unit dose cups of 10.15 mL (81033-002-10); packaged in a carton of 50 unit dose cups
each.
NDC 81033-002-20: 20.3 mL (650mg) unit dose cup
NDC 81033-002-53: Case contains 100 unit dose cups of 20.3 mL (81033-002-20); packaged in a carton of 50 unit dose cups
each. - INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
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PRINCIPAL DISPLAY PANEL
NDC 81033-002-05
Acetaminophen Oral Solution
160mg/5mL
Delivers160mg/5mL
Store at 68° - 77° F
LOT
EXP
PKG by Kesin Pharma
Oldsmar, FL
Alcohol, Dye, Sugar Free
For Institutional Use
NDC 81033-002-10
Acetaminophen Oral Solution
160mg/5mL
Delivers 325mg/10.15mL
Store at 68° - 77° F
LOT
EXP
PKG by Kesin Pharma
Oldsmar, FL
Alcohol, Dye, Sugar Free
For Institutional Use
NDC 81033-002-20
Acetaminophen Oral Solution
160mg/5mL
Delivers 650mg/20.15mL
Store at 68° - 77° F
LOT
EXP
PKG by Kesin Pharma
Oldsmar, FL
Alcohol, Dye, Sugar Free
For Institutional Use
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81033-002(NDC:84447-104) 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) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) POTASSIUM CITRATE (UNII: EE90ONI6FF) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81033-002-40 40 in 1 CARTON 06/30/2021 1 NDC:81033-002-10 10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:81033-002-50 50 in 1 CARTON 06/30/2021 2 NDC:81033-002-05 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 3 NDC:81033-002-30 30 in 1 CARTON 06/30/2021 3 NDC:81033-002-20 20.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 4 NDC:81033-002-55 100 in 1 CASE 06/30/2021 4 NDC:81033-002-05 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 5 NDC:81033-002-54 100 in 1 CASE 06/30/2021 5 NDC:81033-002-10 10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 6 NDC:81033-002-53 100 in 1 CARTON 06/30/2021 6 NDC:81033-002-20 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 06/30/2021 Labeler - Kesin Pharma Corporation (117447816) Establishment Name Address ID/FEI Business Operations Kesin Pharma Corporation 117447816 repack(81033-002) Establishment Name Address ID/FEI Business Operations Kesin Pharma Corporation 119132647 repack(81033-002)