OTC Medication Information: Dye Free Infants Pain and Fever

DYE FREE INFANTS PAIN AND FEVER- acetaminophen suspension
FAMILY DOLLAR SERVICES INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

▪

reduces fever

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relieves minor aches and pains due to:

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the common cold

▪

flu

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headache

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sore throat

▪

toothache

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if your child takes

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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:

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skin reddening

▪

blisters

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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 is allergic to acetaminophen or any of the inactive ingredients in this product

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

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pain gets worse or lasts more than 5 days

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fever gets worse or lasts more than 3 days

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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 for adults as well as for children even if you do not notice any signs or symptoms.

Directions

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this product does not contain directions or complete warnings for adult use.

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do not give more than directed ( see overdose warning)

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shake well before using

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mL = milliliter

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find right dose on chart. If possible, use weight to dose; otherwise, use age.

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push air out of syringe. Insert syringe tip into bottle opening

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flip bottle upside down. Pull yellow part of syringe to correct dose

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dispense liquid slowly into child’s mouth, toward inner cheek

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repeat dose every 4 hours while symptoms last

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do not give more than 5 times in 24 hours

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replace cap tightly to maintain child resistance

Dosing Chart

Weight (lb)	Age (yr)	Dose (mL) **
under 24	under 2 years	ask a doctor
24-35 lbs	2-3 years	5 mL

Attention: use only enclosed syringe specifically designed for use with this product.

Do not use any other dosing device.

Other information

▪

Each 5 mL contains: sodium 2 mg

▪

store at room temperature

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, sodium benzoate, purified water, sodium citrate dihydrate, sorbitol liquid, sucralose, xanthan gum

Questions?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Dye-Free Infants’ Tylenol® Oral Suspension*

NDC 55319-206-02

Dye-Free

Infants’
Pain + Fever

Acetaminophen

Oral Suspension
Pain Reliever-Fever Reducer

Free Of:

•

Dyes

•

Ibuprofen

•

Aspirin

•

Parabens

•

High Fructose Corn Syrup

Natural Grape Flavor

No Added Alcohol

Sugar Free

Use Only Enclosed Syringe

2 FL OZ (60 mL)
160 mg per 5 mL***

***Same as Children’s TYLENOL

*This Product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of the registered trademark Dye-Free Infants’ Tylenol® Oral Suspension.

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING

IMPORTANT: Keep this carton for future reference on full labeling.

DYE FREE INFANTS PAIN AND FEVER acetaminophen suspension

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-206 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg in 5 mL

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED GLYCERIN MICROCRYSTALLINE CELLULOSE WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SOLUTION SUCRALOSE XANTHAN GUM

Product Characteristics Color WHITE (Dye Free) Score Shape Size Flavor GRAPE Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55319-206-02 1 BOTTLE in 1 CARTON contains a BOTTLE 1 60 mL in 1 BOTTLE This package is contained within the CARTON (55319-206-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/08/2023

Labeler — FAMILY DOLLAR SERVICES INC (024472631)

Revised: 09/2023 FAMILY DOLLAR SERVICES INC