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CAROSPIR suspension


  1. Patient Information
  2. Distributed By:
  3. Revised: 8/2018document Id:

Patient Information 

  • Advise patients to take CAROSPIR consistently with respect to food.
  • Patients who receive CAROSPIR should avoid potassium supplements and foods containing high levels of potassium, including salt substitutes.
  • Pregnancy: Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy[seeUse in Specific Populations (8.1)].

Distributed By: 

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16th PLACE

MIAMI, FL 33179

NDC 17856-0120-1

CaroSpir

Spironolactone Oral Suspension
2.5mL Cups 72

For Oral Use Only

Shake well before use

Rx Only

17856-0120-1

CAROSPIR
carospir suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17856-0120(NDC:46287-020)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
spironolactone(UNII: 27O7W4T232) (spironolactone - UNII:27O7W4T232)spironolactone25 mg in 5 mL
Inactive Ingredients
Ingredient NameStrength
xanthan gum(UNII: TTV12P4NEE)
dimethicone(UNII: 92RU3N3Y1O)
sorbic acid(UNII: X045WJ989B)
potassium sorbate(UNII: 1VPU26JZZ4)
saccharin sodium(UNII: SB8ZUX40TY)
anhydrous citric acid(UNII: XF417D3PSL)
trisodium citrate dihydrate(UNII: B22547B95K)
ammonium glycyrrhizate(UNII: 3VRD35U26C)
glycerin(UNII: PDC6A3C0OX)
water(UNII: 059QF0KO0R)
Product Characteristics
ColorwhiteScore
ShapeSize
FlavorBANANAImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-0120-172 in 1 BOX08/22/2018
12.5 mL in 1 CUP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20947808/22/2018
Labeler -ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
ATLANTIC BIOLOGICALS CORP.047437707relabel(17856-0120) , repack(17856-0120)

Revised: 8/2018document Id: 

36a3b4fa-a6a0-4ce2-99b8-fd244e578fe1Set id: 07504afc-f0b6-40f6-8719-cd1c3e67fc35Version: 1Effective Time: 20180822ATLANTIC BIOLOGICALS CORP.



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