![FORMULATION R (PHENYLEPHRINE HYDROCHLORIDE, HYDROGENATE PALM KERNEL OIL) SUPPOSITORY [G&W LABORATORIES, INC.]](https://medic.hrt.org//dailymed/images/a95c678f-84f7-13db-f5b5-05d4d8761fc4/Packaging Carton.jpg)
![FORMULATION R (PHENYLEPHRINE HYDROCHLORIDE, HYDROGENATE PALM KERNEL OIL) SUPPOSITORY [G&W LABORATORIES, INC.]](https://medic.hrt.org//dailymed/images/a95c678f-84f7-13db-f5b5-05d4d8761fc4/Removal of Wrapper Diagram.jpg)
| NDC | 0713-0535-12, 0713-0535-24 |
| Set ID | a95c678f-84f7-13db-f5b5-05d4d8761fc4 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | G&W Laboratories, Inc. |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART346 |
- ACTIVE INGREDIENT
- PURPOSE
-
USES
• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily relieves burning and shrinks hemorrhoidal tissue
• temporarily provides a coating for relief of anorectal discomforts
• temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful -
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 an enlarged prostate
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure or depression
When using this product
• do not use more than directed
Stop use and ask a doctor if
• symptoms get worse or do not get better in 7 days
• bleeding occurs - IF PREGNANT OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with tissue or a soft cloth before insertion of the product.
• remove wrapper before inserting into the rectum as follows:
• hold suppository with pointed end up
• carefully separate tabs with fingernail
• slowly pull apart by pulling tabs down on both sides
• remove suppository from wrapper
• 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: ask a doctor - OTHER INFORMATION
- INACTIVE INGREDIENT
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0713-0535-24
G&W Formulation RTM HEMORRHOIDAL SUPPOSITORIES
Prompt Soothing Relief from Painful Burning, Itching and Discomfort
24 ADULT SUPPOSITORIES
Tamper-Evident: For your safety suppositories are packaged in "Tamper-Evident" sealed foil. Do not use if foil is torn or open
Compare to active ingredients in Preparation-H® Hemorrhoidal Suppositories
FOR TEMPORARY RELIEF FROM PAIN AND ITCHING OF HEMORRHOIDS
-
INGREDIENTS AND APPEARANCE
FORMULATION R
phenylephrine hydrochloride, hydrogenate palm kernel oil suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0713-0535 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 2.5 mg Hydrogenated Palm Kernel Oil (UNII: FM8D1RE2VP) (Hydrogenated Palm Kernel Oil - UNII:FM8D1RE2VP) Hydrogenated Palm Kernel Oil 855 mg Inactive Ingredients Ingredient Name Strength Cod Liver Oil (UNII: BBL281NWFG) Starch, Corn (UNII: O8232NY3SJ) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0713-0535-24 24 in 1 CARTON 2 NDC:0713-0535-12 12 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 06/24/2002 Labeler - G&W Laboratories, Inc. (001271188) Registrant - G&W Laboratories, Inc. (001271188) Establishment Name Address ID/FEI Business Operations G&W Laboratories, Inc. 001271188 MANUFACTURE