Label: PHENYLEPHRINE HYDROCHLORIDE suppository
-
Contains inactivated NDC Code(s)
NDC Code(s): 0363-0394-53, 0363-0394-62 - Packager: Walgreen Company
- 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 February 1, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
-
WARNINGS
For rectal use only.
Ask a doctor before use if you have
- heart disease
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- high blood pressure
- diabetes
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure or depression.
-
DIRECTIONS
Adults:
- When practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue. Gently dry by patting or blotting with toilet tissue or soft cloth before insertion of this product.
- Detach one suppository from strip
- Remove wrapper before inserting into rectum
- Hold suppository with rounded end up and insert tip of fingernail at end marked "peel down"
- Carefully peel film slowly and evenly down both sides to expose suppository
- Insert one suppository into rectum up to 4 times daily especially at night and morning or after each bowel movement
- SPL UNCLASSIFIED SECTION
- STORAGE
- INACTIVE INGREDIENTS
- QUESTIONS
-
BOX INFORMATION - 12 count
Walgreens
NDC 0363-0394-53
Hemorrhoidal
Suppositories- Temporary relief of burning, itching and discomfort
- Shrinks swelling of irritated hemorrhoidal tissue
- Protects irritated tissue
- Also provides nighttime relief
12 SUPPOSITORIES
FOR YOUR SAFETY, SUPPOSITORIES ARE PACKAGED IN TAMPER-EVIDENT SEALED PLASTIC WRAPPER. DO NOT USE IF PLASTIC WRAPPER IS TORN OR OPEN.
*This product is not manufactured or distributed by Wyeth Consumer Healthcare, Inc., owner of the registered trademark Preparation H®.
Distributed by Walgreens Company, Deerfield, IL 60015-4616
100% Satisfaction Guaranteed www.walgreens.com
-
BOX INFORMATION - 24 count
Walgreens
NDC 0363-0394-62
Hemorrhoidal
Suppositories
- Temporary relief of burning, itching and discomfort
- Shrinks swelling of irritated hemorrhoidal tissue
- Protects irritated tissue
- Also provides nighttime relief
Compare to Preparation H Suppositories® active ingredients*
24 SUPPOSITORIES
FOR YOUR SAFETY, SUPPOSITORIES ARE PACKAGED IN TAMPER-EVIDENT SEALED PLASTIC WRAPPER. DO NOT USE IF PLASTIC WRAPPER IS TORN OR OPEN.
*This product is not manufactured or distributed by Wyeth Consumer Healthcare, Inc., owner of the registered trademark Preparation H®.
Distributed by Walgreens Company, Deerfield, IL 60015-4616
100% Satisfaction Guaranteed www.walgreens.com
-
INGREDIENTS AND APPEARANCE
PHENYLEPHRINE HYDROCHLORIDE
phenylephrine hydrochloride suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0394 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength cocoa butter (UNII: 512OYT1CRR) (cocoa butter - UNII:512OYT1CRR) cocoa butter 2077 mg phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) phenylephrine hydrochloride 6 mg shark liver oil (UNII: 4B24275HEU) (shark liver oil - UNII:4B24275HEU) shark liver oil 73 mg Inactive Ingredients Ingredient Name Strength methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) starch, corn (UNII: O8232NY3SJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0394-53 12 in 1 BOX 2 NDC:0363-0394-62 24 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 12/01/2005 Labeler - Walgreen Company (008965063)