Acetaminophen Oral Solution 160Mg Per 5Ml
ACETAMINOPHEN Oral Solution
160mg per 5mL
Acetaminophen
FDA Label NDC 81033-002
15 label sections · Submitted to the FDA by Kesin Pharma Corporation · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kesin Pharma Corporation for the product Acetaminophen (NDC 81033-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding acetaminophen oral solution 160mg per 5ml, active ingredients (in each 5 ml), purpose, uses, warnings, do not use, stop use and ask a doctor if, if pregnant or breast-feedinging, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each 5 Ml)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses
Temporarily relieves minor aches and pains due to:
- headaches
- backaches
- toothaches
- muscular aches
- minor pain of arthritis
- the common cold
- premenstrual and menstrual cramps
- sore throat
- flu
Temporarily reduces fever
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
- skin reddening
- blisters
- rash
Ask a doctor before use if the user has liver disease.
Allergy alert:
Acetaminophen may cause severe skin reactions.
Symptoms may include:
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.
Keep Out Of Reach Of Children.
KEEP OUT OF REACH OF CHILDREN.
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
Citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose
Questions Or Comments?
Call Kesin Pharma at 1-833-537-4679. You may also report serious side effects to this phone number.
Packaged by:
Kesin Pharma
Oldsmar, FL 34677
Effective: 08/2024
Revision 01
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
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