Formulation R

Dosage form: suppository
Ingredients: Phenylephrine Hydrochloride 2.5mg, Hydrogenated Palm Kernel Oil 855mg
Labeler: G&W Laboratories, Inc.
NDC Code: 0713-0535

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.

Formulation RTM Hemorrhoidal Suppositories

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

FORMULATION R  
phenylephrine hydrochloride, hydrogenate palm kernel oil suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0713-0535
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride2.5 mg
Hydrogenated Palm Kernel Oil (Hydrogenated Palm Kernel Oil) Hydrogenated Palm Kernel Oil855 mg
Inactive Ingredients
Ingredient NameStrength
Cod Liver Oil 
Starch, Corn 
Methylparaben 
Propylparaben 
Packaging
#Item CodePackage Description
1NDC:0713-0535-2424 SUPPOSITORY (SUPPOSITORY) in 1 CARTON
2NDC:0713-0535-1212 SUPPOSITORY (SUPPOSITORY) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34606/24/2002
Labeler - G&W Laboratories, Inc. (001271188)
Registrant - G&W Laboratories, Inc. (001271188)
Establishment
NameAddressID/FEIOperations
G&W Laboratories, Inc.001271188MANUFACTURE

Revised: 01/2012
 
G&W Laboratories, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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