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NDC 00113-0279-62 Good Sense Hemorrhoidal 2211; 6.5 mg/1; mg/1 Details
Good Sense Hemorrhoidal 2211; 6.5 mg/1; mg/1
Good Sense Hemorrhoidal is a RECTAL SUPPOSITORY in the HUMAN OTC DRUG category. It is labeled and distributed by L. Perrigo Company. The primary component is COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE.
Product Information
| NDC | 00113-0279 |
|---|---|
| Product ID | 0113-0279_d0a3c9b6-0e55-4630-b76c-4b2de5e802f6 |
| Associated GPIs | 89994002335225 |
| GCN Sequence Number | 071662 |
| GCN Sequence Number Description | phenylephrine HCl/cocoa butter SUPP.RECT 0.25-88.44 RECTAL |
| HIC3 | Q3D |
| HIC3 Description | HEMORRHOIDAL PREPARATIONS |
| GCN | 35585 |
| HICL Sequence Number | 040185 |
| HICL Sequence Number Description | PHENYLEPHRINE HCL/COCOA BUTTER |
| Brand/Generic | Generic |
| Proprietary Name | Good Sense Hemorrhoidal |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | cocoa butter, phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUPPOSITORY |
| Route | RECTAL |
| Active Ingredient Strength | 2211; 6.5 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | L. Perrigo Company |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part346 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00113-0279-62 (00113027962)
| NDC Package Code | 0113-0279-62 |
|---|---|
| Billing NDC | 00113027962 |
| Package | 24 BLISTER PACK in 1 CARTON (0113-0279-62) / 1 SUPPOSITORY in 1 BLISTER PACK |
| Marketing Start Date | 2018-08-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 379f8738-a871-4b09-abd1-c86386dfee04 Details
Uses
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- 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 enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure or depression.
Keep out of reach of children.
Directions
- •
- adults: 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 this product.
- •
- detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:
- •
- hold suppository with rounded end up
- •
- see illustrations: carefully separate foil tabs by inserting tip of fingernail at end marked “peel down”
- •
- slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository
- •
- remove exposed 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 of age: ask a doctor
Inactive ingredients
Package/Label Principal Display Panel
E-Z Open Wrapper
Hemorrhoidal Suppositories
Prompt Soothing Relief from Painful Burning, Itching and Discomfort
Shrinks Swollen Hemorrhoidal Tissue
Protects Irritated Tissue
Also for Nighttime Relief
Reduces Internal Swelling.
Soothes and Protects.
Compare to active ingredients of Preparation H® Hemorrhoidal Suppositories
12 Suppositories
INGREDIENTS AND APPEARANCE
| GOOD SENSE HEMORRHOIDAL
cocoa butter, phenylephrine hcl suppository |
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| Labeler - L. Perrigo Company (006013346) |
Revised: 8/2018
Document Id: d0a3c9b6-0e55-4630-b76c-4b2de5e802f6
Set id: 379f8738-a871-4b09-abd1-c86386dfee04
Version: 3
Effective Time: 20180806