ADULT GLYCERIN LAXATIVE- glycerin suppository 
Major Pharmaceuticals

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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DRUG FACTS

ACTIVE INGREDIENT

 
Glycerin, USP 80.7%

PURPOSE

 
Laxative

USE

 
For relief of occasional constipation

WARNINGS

 
For rectal use only. May cause rectal discomfort or a burning sensation.

Do not use

•
more than one per day
•
for a period of longer than one week unless directed by a doctor
•
laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
•
if seal under product lid is damaged, missing or broken.

Ask a doctor before use

•
if you have noticed a sudden change in bowel habits that persist over a period of two weeks
•
if you are pregnant or nursing a baby

Stop use and ask a doctor

if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

Keep out of reach of children

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

DIRECTIONS

•
Adults and children 6 years of age and older: carefully insert one suppository well into the rectum
•
Do not use more than once per day
•
Generally produces a bowel movement in 15 minutes to 1 hour
•
Children under 6 years of age: ask a doctor.

OTHER INFORMATION

•
Store container tightly closed
•
Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).

INACTIVE INGREDIENTS

sodium stearate, purified water

QUESTIONS?

Adverse Drug Event Call: (800) 616-2471

PACKAGE LABEL - 25 count

MAJOR®                    NDC 0904-2667-17


GLYCERIN
SUPPOSITORIES

Laxative for adults
For the relief of temporary constipation

25 Adult Suppositories

Compare to Fleet® Glycerin Suppositories*

Distributed by:
Major Pharmaceuticals
31178 Enterprise Drive
Livonia, MI 48150 USA

Reorder No. 700478
M-54 Rev 06/08

DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING

*This product is not manufactured or distributed by C.B. Fleet Co., owner of the registered trademark Fleet®.

label 25

PACKAGE LABEL - 100 count

MAJOR®                    NDC 0904-2667-60


GLYCERIN
SUPPOSITORIES

Laxative for adults
For the relief of temporary constipation

100 Adult Suppositories

Compare to Fleet® Glycerin Suppositories*

Distributed by:
Major Pharmaceuticals
31178 Enterprise Drive
Livonia, MI 48150 USA

Re-Order No. 700658
M-54 Rev. 6/08

DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING

*This product is not manufactured or distributed by C.B. Fleet Co., owner of the registered trademark Fleet®.

label 100
ADULT GLYCERIN LAXATIVE 
glycerin suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-2667
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
glycerin (UNII: PDC6A3C0OX) (glycerin - UNII:PDC6A3C0OX) glycerin1.614 g
Inactive Ingredients
Ingredient NameStrength
sodium stearate (UNII: QU7E2XA9TG)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-2667-60100 in 1 JAR; Type 0: Not a Combination Product05/01/200705/25/2014
2NDC:0904-2667-1725 in 1 JAR; Type 0: Not a Combination Product05/01/200705/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/01/200705/30/2015
Labeler - Major Pharmaceuticals (191427277)
Registrant - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
Major Pharmaceuticals191427277REPACK(0904-2667)

Revised: 7/2018
Document Id: e423582a-d8b4-4815-9767-7782ce3dbdcd
Set id: fe7e75c8-0b9d-4bf6-a81f-d454ce479052
Version: 2
Effective Time: 20180719
 
Major Pharmaceuticals