NDC Code(s) : 59741-246-04
Packager : Bio-Pharm, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Childrens Pain ReliefAcetaminophen LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59741-246
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen(UNII: 362O9ITL9D)
(Acetaminophen - UNII:362O9ITL9D) 		Acetaminophen160 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 1450(UNII: OJ4Z5Z32L4)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
GLYCERIN(UNII: PDC6A3C0OX)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SORBITOL(UNII: 506T60A25R)
PRUNUS SEROTINA BARK(UNII: 5D48E975HA)
FD&C RED NO. 40(UNII: WZB9127XOA)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color RED Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59741-246-04118 mL in 1 BOTTLE 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 02/20/2015

PRINCIPAL DISPLAY PANEL

NDC 59741-246-04

Tamper-Evident

For Ages 2-11

BIO-PHARM

Children's
Pain Relief

Oral Solution
Acetaminophen
Fever Reducer / Pain Reliever

Cherry Flavor

  • Alcohol Free
  • Aspirin Free
  • Ibuprofen Free
  • Sugar Free

4 FL OZ (118 mL)
160 mg per 5 mL

See new warnings information

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label