HEMORRHOIDAL- hard fat, phenylephrine hcl suppository

Hemorrhoidal by

Drug Labeling and Warnings

Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, DSC Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in each suppository)

Hard Fat 88.44%

Phenylephrine hydrochloride 0.25%

Purpose

Protectant

Vasoconstrictor

Uses

• temporarily shrinks hemorrhoidal tissue
• gives temporary relief to the itching, burning and discomfort associated with hemorrhoids

Warnings

For rectal use only

Ask a doctor before use if you have

• heart disease
• thyroid disease
• high blood pressure
• diabetes
• trouble urinating due to an enlargedprostate gland

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

• bleeding occurs
• condition worsens or does not improve within 7 days

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 (1-800-222-1222) right away.

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 on 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 rectally up to 4 times daily

children under 12 years: ask a doctor

Other information

store below 30ºC (86ºF) to avoid melting.

Inactive ingredients

corn starch, methylparaben, propylparaben

PRINCIPAL DISPLAY PANEL

The product package shown above represents a sample of that currently in use. Additional packaging may also be available.

Major Hemorrhoidal Suppositories 12ct

Distributed by

Major Pharmaceuticals

17177 N. Laurel Park Drive

Suite 233

Livonia, MI 48152

MajorHemSupp.jpg

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL 
hard fat, phenylephrine hcl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6977
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HARD FAT (UNII: 8334LX7S21) (HARD FAT - UNII:8334LX7S21)	HARD FAT	1.77 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6977-12	2 in 1 CARTON	12/18/2019
1		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	part346	12/18/2019

Labeler - Major Pharmaceuticals (191427277)

Registrant - DSC Laboratories Inc. (097807374)

Establishment
Name	Address	ID/FEI	Business Operations
DSC Laboratories Inc.		097807374	manufacture(0904-6977)