Label: GLYCERIN- glycerin suppository
Contains inactivated NDC Code(s)
NDC Code(s): 17856-0221-1, 17856-0221-2
- Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 46122-221
- 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.
Updated December 19, 2018
If you are a consumer or patient please visit this version.
- Active ingredient (in each suppository)
For rectal use only
May cause rectal discomfort of burning sensation
Ask a Doctor before using any laxative if you have
- abdominal pain, nausea or vomiting
- a sudden change in bowel habits lasting more than two weeks
- already used a laxative for more than 1 week
Stop use and consult a doctor if you have
- rectal bleeding
- no bowel movement after using this product
These symptoms may indicate a serious condition.
- Other information
- Inactive ingredients
- Glycerin Suppositories
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-0221(NDC:46122-221) Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 2.1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-0221-2 30 in 1 BOX, UNIT-DOSE 12/19/2018 1 1 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:17856-0221-1 60 in 1 BOX, UNIT-DOSE 12/19/2018 2 1 in 1 POUCH; 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 part334 12/19/2018 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations ATLANTIC BIOLOGICALS CORP. 047437707 repack(17856-0221) , relabel(17856-0221)