EXTRA STRENGTH STOOL SOFTENER LAXATIVE - docusate sodium capsule, liquid filled
Bryant Ranch Prepack

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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Rugby Extra Strength Stool Softener Laxative

Active Ingredient (in each softgel)

Docusate Sodium 250mg

Purpose

Stool softener

Uses

Relieves occasional constipation.
Generally produces bowel movement within 12 to72 hours.

Warnings - Do not use

for longer than one week
if you are taking mineral oil
when abdominal pain, nausea, or vomiting are present

Ask a doctor before use if

you have a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

you experience rectal bleeding
you fail to have a bowel movement after using this product

These may indicate a serious condition.

If pregnant or breastfeeding

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children over 12 years and over:1 capsule once daily
children under 12 years: ask a doctor

Other information

store at controlled room temperature 15 - 30 degrees C (59-86 degrees F)

Each capsule contains sodium 15mg

Inactive Ingredients

edible white ink, FDandC Red No. 40, FDandC Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special.

Questions or comments?

Call 1-800-645-2158, 9am - 5am ET Monday - Friday

Product Labeling

Rugby Extra Strength Stool Softener Laxative
Docusate Sodium USP, 250mg

Mfd for: Rugby Laboratories, Inc
Duluth Georgia 30097
www.rugbylaboratories.com

HOW SUPPLIED

Product: 63629-3213

NDC: 63629-3213-1 30 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 63629-3213-2 60 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 63629-3213-3 100 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 63629-3213-4 7 CAPSULE, LIQUID FILLED in a BOTTLE

Docusate Sodium 250mg Capsule

EXTRA STRENGTH STOOL SOFTENER LAXATIVE
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63629-3213(NDC:0536-3757)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	orange (orange)	Score	no score
Shape	OVAL (OVAL)	Size	20mm
Flavor		Imprint Code	P20
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63629-3213-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2012	07/23/2018
2	NDC:63629-3213-2	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2012	07/23/2018
3	NDC:63629-3213-3	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2012	07/23/2018
4	NDC:63629-3213-4	7 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2012	07/23/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/29/2012	07/23/2018

Labeler - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(63629-3213) , RELABEL(63629-3213)

Revised: 5/2021

Document Id: 2c096121-78a8-4283-bc1b-6a25c118ab0e

Set id: 43187e13-bb39-4f81-9c8f-bd5fae95686a

Version: 1002

Effective Time: 20210530

Bryant Ranch Prepack