Label: DYE FREE CHILDRENS ACETAMINOPHEN- acetaminophen suspension
- NDC Code(s): 68094-061-59, 68094-061-61, 68094-061-62
- Packager: Precision Dose Inc.
- This is a repackaged label.
- Source NDC Code(s): 0113-8959
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 16, 2025
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- Purpose
- Uses
-
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
When using this product do not exceed recommended dose (see overdose warning)
-
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
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Questions or comments?
- How Supplied
- SPL UNCLASSIFIED SECTION
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
-
INGREDIENTS AND APPEARANCE
DYE FREE CHILDRENS ACETAMINOPHEN
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68094-061(NDC:0113-8959) 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) CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505) CARRAGEENAN (UNII: 5C69YCD2YJ) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X) Product Characteristics Color WHITE (opaque,viscous) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68094-061-62 3 in 1 CASE 08/02/2022 1 10 in 1 TRAY 1 NDC:68094-061-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:68094-061-61 10 in 1 CASE 08/02/2022 2 10 in 1 TRAY 2 NDC:68094-061-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M013 08/02/2022 Labeler - Precision Dose Inc. (035886746)