Label: BLISS GVS HEMORRHOIDAL- phenylephrine hcl suppository
- NDC Code(s): 72701-111-12, 72701-111-24, 72701-111-48
- Packager: Bliss GVS Pharma Limited
- 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 May 30, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
-
Warnings
For rectal use only
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
-
Directions
- when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.
- gently dry by patting or blotting with a tissue or a soft cloth before insertion of suppository.
- detach one suppository from the strip
- separate the two tabs of the white plastic wrap
- with thumb and forefinger of each hand, grasp the tabs and peel downward, unwrapping the suppository
- insert one suppository into the rectum
adults and children 12 years and over: insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement
children under 12 years of age: ask a doctor
- Other information
- Inactive ingredient
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL
HEMORRHOIDAL SUPPOSITORIES
NDC 72701-111-12
Prevents Further Irritation
Reduces Internal Hemorrhoidal Swelling
Prompt Relief from Itching and Discomfort
Also for Nighttime ReliefBliss GVS
12 Suppositories
Manufactured and Marketed by:
BLISS GVS PHARMA LTD.
102, Hyde Park, Saki Vihar Road, Andheri (E),
Mumbai-400 072, INDIA
Email: info@blissgvs.com • www.blissgvs.com
-
INGREDIENTS AND APPEARANCE
BLISS GVS HEMORRHOIDAL
phenylephrine hcl suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72701-111 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 6.25 mg Inactive Ingredients Ingredient Name Strength HARD FAT (UNII: 8334LX7S21) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72701-111-12 2 in 1 CARTON 05/25/2023 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:72701-111-24 4 in 1 CARTON 05/25/2023 2 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:72701-111-48 8 in 1 CARTON 05/25/2023 3 6 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M015 05/25/2023 Labeler - Bliss GVS Pharma Limited (675629890) Establishment Name Address ID/FEI Business Operations Bliss GVS Pharma Limited 675630493 manufacture(72701-111)