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NDC 63868-0208-24 Hemorrhoidal 1768.8; 5 mg/1; mg/1 Details

Hemorrhoidal 1768.8; 5 mg/1; mg/1

Hemorrhoidal is a RECTAL SUPPOSITORY in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association, Inc.. The primary component is COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE.

Product Information

NDC	63868-0208
Product ID	63868-208_c2b05115-160d-7c65-e053-2995a90a13fd
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	Hemorrhoidal
Proprietary Name Suffix	n/a
Non-Proprietary Name	COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SUPPOSITORY
Route	RECTAL
Active Ingredient Strength	1768.8; 5
Active Ingredient Units	mg/1; mg/1
Substance Name	COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Chain Drug Marketing Association, Inc.
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	2023-12-31

Package

Package Images

NDC 63868-0208-24 (63868020824)

Pricing Information	N/A
NDC Package Code	63868-208-24
Billing NDC	63868020824
Package	24 BLISTER PACK in 1 BOX (63868-208-24) / 1 SUPPOSITORY in 1 BLISTER PACK
Marketing Start Date	2021-05-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a01ee29d-02ca-4473-aa90-c2e8174dba26 Details

Active Ingredients

Active Ingredients

(per suppository)

Cocoa butter 88.44 %

Phenylephrine hydrochloride 0.25 %

Purposes

Protectant

Vasoconstructor

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

temporarily shrinks hemorrhoidal tissues
gives temporary relief to the itching, burning and discomfort associated with hemorrhoids
aids in protecting irritated anorectal areas

Warnings

For rectal use only

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure or depression

Ask a doctor before use if you have

heart disease
thyroid disease
high blood pressure
diabetes
difficulty in urination due to enlargement of the prostate gland

When using this product

do not exceed the recommended daily dosage unless directed by a doctor
in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly

If pregnant or breast-feeding

ask a health professional before use.

Directions Adults

detach one suppository from the strip. Remove the wrapper before inserting into the rectum.
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: consult doctor

Other Information

Store at room temperature or in a cool place but not over 80° F

Inactive ingredients

methylparaben, propylparaben, starch

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL

cocoa butter, phenylephrine hydrochloride suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-208
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)	COCOA BUTTER	1768.8 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-208-12	12 in 1 BOX	05/18/2021
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:63868-208-24	24 in 1 BOX	05/18/2021
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	09/26/2007

Labeler - Chain Drug Marketing Association, Inc. (011920774)

Registrant - Acino Products, LLC. (019385518)

Name	Address	ID/FEI	Business Operations
Establishment
Acino Products, LLC.		019385518	manufacture(63868-208)

Revised: 5/2021

Document Id: c2b05115-160d-7c65-e053-2995a90a13fd

Set id: a01ee29d-02ca-4473-aa90-c2e8174dba26

Version: 3

Effective Time: 20210519