Dye Free Childrens Acetaminophen ACETAMINOPHEN PRECISION DOSE INC. FDA Approved Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
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Substance Acetaminophen
Route
ORAL
Applications
M013

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL) Acetaminophen 160 mg
Inactive Ingredients
Inactive ingredients anhydrous citric acid calcium sulfate carrageenan flavor glycerin hydroxyethyl cellulose microcrystalline cellulose and carboxymethylcellulose sodium propylene glycol purified water sodium benzoate sorbitol solution sucralose tribasic sodium phosphate
Strengths
5 ml/unit 5 ml 160 mg
Quantities
5 ml
Treats Conditions
Uses Temporarily Reduces Fever Relieves Minor Aches And Pains Due To The Common Cold Flu Headache Sore Throat Toothache
Pill Appearance
Color: white

Identifiers & Packaging

Container Type UNKNOWN
UNII
362O9ITL9D
Packaging

How Supplied NDC 68094-061-61 5 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-061-62 5 mL per unit dose cup Thirty (30) cups per shipper; PRINCIPAL DISPLAY PANEL - 5 mL Cup Label NDC 68094-061-59 PrecisionDose™ Children's ACETAMINOPHEN Oral Suspension, 160 mg/5 mL Dye Free Pkg: Precision Dose, Inc., S. Beloit, IL 61080 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

Package Descriptions
  • How Supplied NDC 68094-061-61 5 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-061-62 5 mL per unit dose cup Thirty (30) cups per shipper
  • PRINCIPAL DISPLAY PANEL - 5 mL Cup Label NDC 68094-061-59 PrecisionDose™ Children's ACETAMINOPHEN Oral Suspension, 160 mg/5 mL Dye Free Pkg: Precision Dose, Inc., S. Beloit, IL 61080 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

Overview

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

Indications & Usage

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

Dosage & Administration

Directions Use as directed per healthcare professional. this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning ) shake well before using mL = milliliter find right dose on chart below. If possible, use weight to dose; otherwise, use age. repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) or as directed by a doctor under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL 36-47 4-5 years 7.5 mL 48-59 6-8 years 10 mL 60-71 9-10 years 12.5 mL 72-95 11 years 15 mL

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 a 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. if your child has ever had an allergic reaction to this product or any of its ingredients 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 When using this product do not exceed recommended dose (see overdose warning ) Stop use and ask a doctor if 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. 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 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. if your child has ever had an allergic reaction to this product or any of its ingredients

When Using

When using this product do not exceed recommended dose (see overdose warning )

Stop Use & Ask a Doctor

Stop use and ask a doctor if 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.

Storage & Handling

Other information each 5 mL contains: sodium 3 mg store at 20-25°C (68-77°F)

Questions

Questions or comments? 1-800-397-9228 For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]


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