Active Ingredients (In Each 5 Ml)
Acetaminophen 160 mg
Acetaminophen
FDA Label NDC 81033-002
Full FDA labeling including 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 active ingredients (in each 5 ml), purpose, uses, warnings, ask a doctor before use, ask a doctor or pharmacist before use, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Uses
Temporarily:
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
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
- skin reddening
- blisters
- rash
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: 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 Before Use
Ask a doctor before use if the user has liver disease.
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.
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
each 5 mL contains: sodium 8 mg
store at 20 -25°C (68 -77°F)
tamper evident: DO NOT use if foil on cup is missing or torn
Alcohol Free, Dye Free, Sugar Free
Inactive Ingredients
Citric acid, grape flavor[Ma1] , edetate disodium, glycerin, maltitol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum
grape flavor
Questions Or Comments?
Call 1-833-537-4679
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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