Label: DYE FREE INFANTS PAIN AND FEVER- acetaminophen suspension
- NDC Code(s): 55319-206-02
- Packager: FAMILY DOLLAR SERVICES INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated September 16, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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 55319-206-02
Dye-Free
Infants'
Pain + FeverAcetaminophen
Oral Suspension
Pain Reliever-Fever ReducerFree Of:
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- Dyes
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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
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.
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INGREDIENTS AND APPEARANCE
DYE FREE INFANTS PAIN AND FEVER
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-206 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:55319-206-02 1 in 1 CARTON 05/08/2023 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 not final part343 05/08/2023 Labeler - FAMILY DOLLAR SERVICES INC (024472631)