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Hemorrhoidal by Acino Products, LLC.

Dosage form: suppository
Ingredients: COCOA BUTTER 1768.8mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Acino Products, LLC.
NDC Code: 68784-101

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.

Drug Facts Active Ingredients

Active Ingredients
(per suppository)

Cocoa butter 88.44 %
Phenylephrine hydrochloride 0.25 %

Purpose

Protectant
Vasoconstructor

Keep out of reach of children.

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 th 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

Hemorrhoidal Suppositories Label

HEMORRHOIDAL SUPPOSITORIES

12 SUPPOSITORIES

NDC68784-101-12

*Compare to the active ingredient in PREPARATION H®

Acino Products

Hemorrhoidal Suppositories

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

12 SUPPOSITORIES

Tamper-evident: for your safety, suppositories are packed in tamper-evident sealed wrapper. Do not use if wrapper is torn or open.

Easy Open

Manufactured by:
Acino Products, LLC
Hamilton, NJ 08691
MADE IN USA

*This product is not manufactured or distributed by Pfizer Consumer Healthcare., distributor of Preparation H®.


HEMORRHOIDAL 
cocoa butter, phenylephrine hydrochloride suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68784-101
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:68784-101-1212 BLISTER PACK (BLISTER PACK) in 1 BOX
11 SUPPOSITORY (SUPPOSITORY) in 1 BLISTER PACK
2NDC:68784-101-2424 BLISTER PACK (BLISTER PACK) in 1 BOX
21 SUPPOSITORY (SUPPOSITORY) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/01/2014
Labeler - Acino Products, LLC. (019385518)
Registrant - Acino Products, LLC. (019385518)
Establishment
NameAddressID/FEIOperations
Acino Products, LLC.019385518manufacture(68784-101)

 
Acino Products, LLC.

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Medically reviewed on Jun 25, 2018

Further information

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

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