equaline childrens acetaminophen ACETAMINOPHEN UNITED NATURAL FOODS, INC. DBA UNFI 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
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL) Acetaminophen 160 mg
Inactive Ingredients
Inactive ingredients anhydrous citric acid butylparaben calcium sulfate carrageenan D&C red #33 FD&C red #40 flavor glycerin high fructose corn syrup hydroxyethyl cellulose microcrystalline cellulose and carboxymethylcellulose sodium propylene glycol purified water sodium benzoate sorbitol solution tribasic sodium phosphate
Strengths
5 ml 160 mg
Quantities
5 ml 118 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: red

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D
Packaging

Principal Display Panel compare to Children’s Tylenol ® Oral Suspension active ingredient EQUALINE ® children’s acetaminophen 160mg per 5mL (pain reliever/fever reducer) oral suspension fast, effective relief of children’s fever and pain for ages 2 to 11 years bubble gum flavor ASPIRIN FREE IBUPROFEN FREE ALCOHOL FREE PARABEN FREE 4 FL OZ (118mL) childrens acetaminophen-image

Package Descriptions
  • Principal Display Panel compare to Children’s Tylenol ® Oral Suspension active ingredient EQUALINE ® children’s acetaminophen 160mg per 5mL (pain reliever/fever reducer) oral suspension fast, effective relief of children’s fever and pain for ages 2 to 11 years bubble gum flavor ASPIRIN FREE IBUPROFEN FREE ALCOHOL FREE PARABEN FREE 4 FL OZ (118mL) childrens acetaminophen-image

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 • 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. • remove the child protective cap and squeeze your child’s dose into the dosing cup • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL)* 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 *or as directed by a doctor Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

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. • 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. 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.

Storage & Handling

Other information • each 5 mL contains: sodium 3 mg • store at 20-25 ° C (68-77 ° F) • do not use if printed neckband is broken or missing

Questions

Questions or comments? 1-855-423-2630


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