Formulation R
FDA Label NDC 0713-0535

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by G&w Laboratories, Inc. for the product Formulation R (NDC 0713-0535). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, if pregnant or breast feeding, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

* Please review the disclaimer below.