NDC | 68094-015-59, 68094-015-61, 68094-015-62 |
Set ID | 86961ee1-7f04-4bb6-a9a0-0337f7978122 |
Category | HUMAN OTC DRUG LABEL |
Packager | Precision Dose, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- 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)