Acetaminophen ACETAMINOPHEN ONCOR PHARMACEUTICALS FDA Approved Uses For the temporary relief of minor aches and pains associated with: • the common cold • flu • sore throat • headache • toothache • and to reduce fever
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Substance Acetaminophen
Route
ORAL
Applications
M013

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL teaspoonful) Acetaminophen USP 160 mg
Inactive Ingredients
Inactive ingredients Cherry Flavor Citric Acid FD&C Red No. 40 Glycerin Polyethylene Glycol Purified Water Sodium Benzoate Sodium Citrate Sodium Saccharin Sorbitol Solution Sucralose.
Strengths
5 ml 160 mg
Quantities
5 ml 473 ml 118 ml
Treats Conditions
Uses For The Temporary Relief Of Minor Aches And Pains Associated With The Common Cold Flu Sore Throat Headache Toothache And To Reduce Fever
Pill Appearance
Color: red

Identifiers & Packaging

Container Type UNKNOWN
UPC
0383720500167
UNII
362O9ITL9D
Packaging

PRINCIPAL DISPLAY PANEL ONCOR PHARMACEUTICALS NDC 83720- 500 -16 Pain and Fever Relief kids Acetaminophen Liquid 160 mg / 5 mL Alcohol Free Sugar Free Aspirin Free Ibuprofen Free Cherry Flavor 16 fl. oz. - 473 mL ONCOR PHARMACEUTICALS NDC 83720- 500-16 Pain and Fever Relief kids Acetaminophen Liquid 160 mg / 5 mL Alcohol Free Sugar Free Aspirin Free Ibuprofen Free Cherry Flavor 4 fl. oz. - 118 mL Acetaminophen-16 Acetaminophen-04

Package Descriptions
  • PRINCIPAL DISPLAY PANEL ONCOR PHARMACEUTICALS NDC 83720- 500 -16 Pain and Fever Relief kids Acetaminophen Liquid 160 mg / 5 mL Alcohol Free Sugar Free Aspirin Free Ibuprofen Free Cherry Flavor 16 fl. oz. - 473 mL ONCOR PHARMACEUTICALS NDC 83720- 500-16 Pain and Fever Relief kids Acetaminophen Liquid 160 mg / 5 mL Alcohol Free Sugar Free Aspirin Free Ibuprofen Free Cherry Flavor 4 fl. oz. - 118 mL Acetaminophen-16 Acetaminophen-04

Overview

Uses For the temporary relief of minor aches and pains associated with: • the common cold • flu • sore throat • headache • toothache • and to reduce fever

Indications & Usage

Uses For the temporary relief of minor aches and pains associated with: • the common cold • flu • sore throat • headache • toothache • and to reduce fever

Dosage & Administration

Directions this product does not contain directions or complete warnings for adult use Use only the enclosed dosing cup designed for use with this product. if possible, use weight to dose, otherwise use age. dose may be repeated every 4 hours, while symptoms persist, up to five times a day or as directed by a doctor. Weight (lbs.) Age (years) Dosage Teaspoonful (tsp)* Under 24 Under 2 Consult a doctor 24 to 35 2 to under 4 5 mL (1 tsp) 36 to 47 4 to under 6 7.5 mL (1 1/2 tsp) 48 to 59 6 to under 9 10 mL (2 tsp) 60 to 71 9 to under 11 12.5 mL (2 1/2 tsp) 72 to 95 11 to under 12 15 mL (3 tsp) * or as directed by a doctor

Warnings & Precautions
Warnings: Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: • more than 5 doses in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen 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, 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. Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. Stop use and ask a doctor if • pain gets worse or lasts more than 5 days pain gets worse or lasts more than 5 day. fever gets worse or lasts more than 3 days redness or swelling is present. any new symotom appear. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Purpose

Purpose Pain reliever/Fever reducer

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Storage & Handling

Other information Each 5 mL contains: Sodium 3 mg If dispensed, dispense in a tight, light resistant container with a child-resistant cap. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)

Questions

Questions? You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.


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