HEMORRHOIDAL- cocoa butter, phenylephrine hydrochloride suppository 
Chain Drug Marketing Association, Inc.

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.

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Chain Drug Marketing Association - Hemorrhoidal Suppository

Active Ingredients

Active Ingredients
(per suppository)

Cocoa butter 88.44 %
Phenylephrine hydrochloride 0.25 %

Purposes

Protectant
Vasoconstructor

Keep out of reach of children.

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

Uses

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

When using this product

If pregnant or breast-feeding

ask a health professional before use.

Directions Adults

Other Information

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

Inactive ingredients

methylparaben, propylparaben, starch

01b UC_Hemorrhoidal Suppositories_12pk_PDP

01b UC_Hemorrhoidal Suppositories_12pk_DF box

HEMORRHOIDAL 
cocoa butter, phenylephrine hydrochloride suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-208
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER1768.8 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STARCH, CORN (UNII: O8232NY3SJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-208-1212 in 1 BOX05/18/2021
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63868-208-2424 in 1 BOX05/18/2021
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34609/26/2007
Labeler - Chain Drug Marketing Association, Inc. (011920774)
Registrant - Acino Products, LLC. (019385518)
Establishment
NameAddressID/FEIBusiness Operations
Acino Products, LLC.019385518manufacture(63868-208)

Revised: 5/2021
Document Id: c2b05115-160d-7c65-e053-2995a90a13fd
Set id: a01ee29d-02ca-4473-aa90-c2e8174dba26
Version: 3
Effective Time: 20210519
 
Chain Drug Marketing Association, Inc.