Label: DYE FREE CHILDRENS ACETAMINOPHEN- acetaminophen suspension
- NDC Code(s): 68094-015-59, 68094-015-61, 68094-015-62
- Packager: Precision Dose, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0113-0397
- 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 November 12, 2020
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
-
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
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
- How Supplied
- 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:68094-015(NDC:0113-0397) 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 form (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 Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68094-015-62 3 in 1 CASE 01/13/2017 1 10 in 1 TRAY 1 NDC:68094-015-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:68094-015-61 10 in 1 CASE 08/17/2017 2 10 in 1 TRAY 2 NDC:68094-015-59 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 NOT FINAL part343 01/13/2017 Labeler - Precision Dose, Inc. (035886746)
