Label: ACETAMINOPHEN solution
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NDC Code(s):
81033-002-05,
81033-002-10,
81033-002-20,
81033-002-30, view more81033-002-31, 81033-002-40, 81033-002-41, 81033-002-50, 81033-002-51
- Packager: Kesin Pharma Corporation
- 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 January 16, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- Active Ingredients (in each 5 mL)
- PURPOSE
- USES
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WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than more than 5 doses in in 24 hours, which is the maximum daily amount for this product
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has more alcoholic drinks everyday while using this product
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: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years or age unless directed by physician.
Ask a doctor or pharmacist before use
Do no 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.
Ask a doctor or pharmacist before use If the user is taking the blood thinning drug warfarin.
If pregnant or breast-feeding, ask a health professional before use.
Stop use and ask a doctor if
Stop use and ask a doctor if
- symptoms do not improve
- 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.
Keep out of reach of children.
Keep out of reach of children.
Overdose warning: 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.
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DIRECTIONS
- do not take more than directed (see overdose warning)
- do not take more than 5 doses in any 24-hour period
- dose as follows or as directed by doctor:
- take only with dosing cup provided
- adults and children 12 years of age and older: 20 mL (640 mg) in dosing cup every 6 hours
- children under 12 years of age: ask a doctor
- this product does not contain directions or complete warnings for use
- OTHER INFORMATION
- 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 Phoenix, AZ
Alcohol, Dye, Sugar Free
NDC 81033-002-10
Acetaminophen Oral Solution
160mg/5mL
Delivers 325mg/10.15mL
Store at 68° - 77° F
LOT
EXP
PKG by
Kesin Pharma Phoenix, AZ
Alcohol, Dye, Sugar Free
NDC 81033-002-20
Acetaminophen Oral Solution
160mg/5mL
Delivers 650mg/20.15mL
Store at 68° - 77° F
LOT
EXP
PKG by
Kesin Pharma Phoenix, AZ
Alcohol, Dye, Sugar Free
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81033-002 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 EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81033-002-41 8 in 1 CASE 06/30/2021 1 NDC:81033-002-40 40 in 1 CARTON 1 NDC:81033-002-10 10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:81033-002-51 8 in 1 CASE 06/30/2021 2 NDC:81033-002-50 50 in 1 CARTON 2 NDC:81033-002-05 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 3 NDC:81033-002-31 8 in 1 CASE 06/30/2021 3 NDC:81033-002-30 30 in 1 CARTON 3 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 not final part343 06/30/2021 Labeler - Kesin Pharma Corporation (117447816)