Label: DYE FREEINFANTS PAIN AND FEVER- acetaminophen suspension
- NDC Code(s): 0363-6020-02
- Packager: WALGREEN COMPANY
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 13, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- Purpose
- Uses
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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
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- with other drugs containing acetaminophen
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include:
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- skin reddening
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
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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 (seeoverdose 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
- Other information
- Inactive ingredients
- Questions?
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PRINCIPAL DISPLAY PANEL
Compare to the active ingredient in Dye-Free Infants’ Tylenol® Oral Suspension*
NDC 0363-6020-02
Dye-Free
Infants'
Pain + FeverAcetaminophen
Oral Suspension
Pain Reliever-Fever ReducerFree Of:
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- Dyes
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- Sugar Free
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- Ibuprofen
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- Aspirin
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- Parabens
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- High Fructose Corn Syrup
Natural Grape Flavor
No Added Alcohol
Use Only Enclosed Syringe2 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.
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INGREDIENTS AND APPEARANCE
DYE FREEINFANTS PAIN AND FEVER
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-6020 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL SOLUTION (UNII: 8KW3E207O2) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (Dye Free) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-6020-02 1 in 1 CARTON 10/10/2022 1 60 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 10/10/2022 Labeler - WALGREEN COMPANY (008965063)
