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Hemorrhoidal by GRAXCELL PHARMACEUTICAL, LLC

Dosage form: suppository
Ingredients: COCOA BUTTER 1768.8mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: GRAXCELL PHARMACEUTICAL, LLC
NDC Code: 70795-1021

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.

Active Ingredients (per suppository)

Cocoa butter 88.44 %

Phenylephrine hydrochloride 0.25 %

Purpose

Protectant

Vasoconstructor

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.

Keep out of reach of children

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

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

Hemorrhoidal Suppositories Label

GRAXCELL PHARMACEUTICAL, LLC.

NDC 70795-1021-2

*Compare to active ingredients in PREPARATION H

Hemorrhoidal Suppositories

HELPS REDUCE INFLAMMATION AND SWELLING OF HAEMORRHOIDAL TISSUES PROVIDES TEMPORARY RELIEF IN MANY CASES

12 SUPPOSITORIES



GRAXCELL PHARMACEUTICAL, LLC.

NDC 70795-1021-4

*Compare to active ingredients in PREPARATION H

Hemorrhoidal Suppositories

Reduces Internal Swelling I Soothes and Protects

Cocoa Butter 88.44% I Phenylephrine Hydrochloride 0.25%

Prompt Soothing Relief From Painful Burning, Itching and Discomfort Provide Additional Nighttime Relief

24 Suppositories



HEMORRHOIDAL  
cocoa butter, phenylephrine hydrochloride suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70795-1021
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COCOA BUTTER (COCOA BUTTER) COCOA BUTTER1768.8 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN 
PROPYLPARABEN 
STARCH, CORN 
Packaging
#Item CodePackage Description
1NDC:70795-1021-212 BLISTER PACK in 1 BOX
11 SUPPOSITORY in 1 BLISTER PACK
2NDC:70795-1021-424 BLISTER PACK in 1 BOX
21 SUPPOSITORY in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/29/2017
Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)
Registrant - GRAXCELL PHARMACEUTICAL, LLC. (056556923)

 
GRAXCELL PHARMACEUTICAL, LLC

← See all Hemorrhoidal brands

Medically reviewed on Jun 15, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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