Childrens Tukol Acetaminophen Fever Reducer Pain Reducer

ACETAMINOPHEN ORAL HUMAN OTC DRUG

Childrens Tukol Acetaminophen Fever Reducer Pain Reducer is an FDA drug label for the active ingredient ACETAMINOPHEN manufactured by Genomma Lab USA, Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20170415.

Generic name
ACETAMINOPHEN
Manufacturer
Genomma Lab USA, Inc.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
50066-525
Application
part343
Label effective
20170415

Active ingredients

Drug Facts Active ingredient (in each 5 mL = 1 teaspoonful) Acetaminophen 160 mg

Indications & Usage

Uses temporarily reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache

Dosage & Administration

Directions * product is not labeled with directions or complete warning for adult use Shake well before using 1mL = milliliter; tsp = teaspoonful find the right dose on chart below. If posssible, use weight to dose: otherwise use age. if needed, repeat dose every 4 hours while symptons last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor weight (lb) age dose (mL or tsp) under 24 under 2 years ask a doctor 24 - 35 2 - 3 years 5 mL (1 tsp) 36- 47 4 - 5 years 7.5 mL (1 1/2 tsp) 48 - 59 6 - 8 years 10 mL (10 mL (2 tsp) 60- 71 9 - 10 years 12.5 mg (2 1/2 tsp) 72 95 11 years 15 mL (3 tsp) use only enclosed dosing cup specfically designed for use with this product

Contraindications

Not available.

Warnings

Warnings Liver warning: This product cantains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours which is the maxium daily amount with other drugs containing acetaminophen Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If skin reaction occurs, stop use and seek medical help right away. Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomitting, consult a doctor promptly.

Adverse Reactions

Not available.

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