Acetaminophen ACETAMINOPHEN PROFICIENT RX LP FDA Approved Uses temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • arthritis • the common cold • toothache • menstrual cramps • reduces fever
FunFoxMeds bottle
Substance Acetaminophen
Route
ORAL
Applications
M013
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL teaspoonful) Acetaminophen USP 160 mg
Inactive Ingredients
Inactive ingredients Bitter Mask Cherry Flavor Citric Acid FD&C Red No. 40 Glycerin Polyethylene Glycol Purified Water Sodium Benzoate Sodium Citrate Dihydrate Sodium Saccharin Sorbitol.
Strengths
5 ml 160 mg
Quantities
118 ml 5 ml
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache Muscular Aches Backache Arthritis The Common Cold Toothache Menstrual Cramps Reduces Fever
Pill Appearance
Color: red

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UPC
0371205730048
UNII
362O9ITL9D
Packaging

PRINCIPAL DISPLAY PANEL – 4 fl. oz. (118 mL) Bottle Label NDC 71205-730-04 Acetaminophen Liquid 160 mg/5 mL Pain Reliever / Fever Reducer Sugar Free / Alcohol Free Aspirin Free CHERRY FLAVOR 4 fl. oz. (118 mL) 71205-730-04

Package Descriptions
  • PRINCIPAL DISPLAY PANEL – 4 fl. oz. (118 mL) Bottle Label NDC 71205-730-04 Acetaminophen Liquid 160 mg/5 mL Pain Reliever / Fever Reducer Sugar Free / Alcohol Free Aspirin Free CHERRY FLAVOR 4 fl. oz. (118 mL) 71205-730-04

Overview

Uses temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • arthritis • the common cold • toothache • menstrual cramps • reduces fever

Indications & Usage

Uses temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • arthritis • the common cold • toothache • menstrual cramps • reduces fever

Dosage & Administration

Directions Do not exceed recommended dosage. Overdose Warnings Taking more than the recommended dose (overdose) can cause serious health problems, including liver damage. • adults and children 12 years of age and older: take 2 teaspoonfuls (10 mL) every 6 hours; do not exceed 8 teaspoonfuls (40 mL) in 24 hours • children under 12 years of age: Under the direct guidance of a licensed professional, doctor, or pharmacist.

Warnings & Precautions
Warnings Liver Warning This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 teaspoonfuls (40 mL) in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day 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. Ask a doctor before use if you have health issues especially liver disease. Ask a doctor or pharmacist before use if you are taking other drugs, including the blood thinner warfarin. 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 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor • if you are allergic to acetaminophen or any of the inactive ingredients in this product. Stop use and ask a doctor if • new symptoms occur such as rash, hives, itching or hoarseness • redness or swelling is present • pain gets worse or lasts for more than 10 days • fever gets worse or lasts for more than 3 days • symptoms do not improve These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. 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 even if you do not notice any signs or symptoms.
Purpose

Purpose Pain reliever/fever reducer

Do Not Use

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 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Stop Use & Ask a Doctor

Stop use and ask a doctor if • new symptoms occur such as rash, hives, itching or hoarseness • redness or swelling is present • pain gets worse or lasts for more than 10 days • fever gets worse or lasts for more than 3 days • symptoms do not improve These could be signs of a serious condition.

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 even if you do not notice any signs or symptoms.

Storage & Handling

Other information 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 Westminster M-F (9 a.m. to 5 p.m. EST), at 1-844-7294 or FDA at 1-800-FDA-1088.


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