FORMULATION R- phenylephrine hydrochloride, hydrogenate palm kernel oil suppository

Formulation R by

Drug Labeling and Warnings

Formulation R by is a Otc medication manufactured, distributed, or labeled by G&W Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hard Fat 85.5%
Phenylephrine HCl 0.25%

PURPOSE

● Protectant
● Vasoconstrictor

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

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

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

store at 20-25˚C (68-77˚F)

INACTIVE INGREDIENT

cod liver oil, corn starch, methylparaben, propylparaben

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 suppository

Product 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