Label: PREMIER VALUE HEMORRHOIDAL- hemorrhoidal rectal suppositories suppository
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Contains inactivated NDC Code(s)
NDC Code(s): 68016-321-12, 68016-321-13 - Packager: Chain Drug Consortium
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 March 25, 2015
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- Drug Facts
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- Ask a doctor or pharmacist before use if you are
- Ask a doctor before use if you have
- When using this product
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Product Label
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INGREDIENTS AND APPEARANCE
PREMIER VALUE HEMORRHOIDAL
hemorrhoidal rectal suppositories suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-321 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER 88.44 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE .25 g in 100 g Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) .02 g in 100 g PROPYLPARABEN (UNII: Z8IX2SC1OH) .02 g in 100 g MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) 11.27 g in 100 g Product Characteristics Color white Score Shape BULLET Size 32mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-321-13 2 in 1 CARTON 1 NDC:68016-321-12 12 g in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 03/25/2015 Labeler - Chain Drug Consortium (101668460) Establishment Name Address ID/FEI Business Operations Unipack, Inc. 009248480 manufacture(68016-321)