ONELAX- bisacodyl suppository

OneLAX by

Drug Labeling and Warnings

OneLAX by is a Otc medication manufactured, distributed, or labeled by AKRON PHARMA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (per suppository)

Bisacodyl USP, 10  mg

Purpose

Laxative

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

• for relief of occasional constipation
• this product usually produces bowel movement in 1/4 to 1 hour
  

Warnings

For rectal use only.

Do not use laxative products

• when abdominal pain, nausea or vomiting are present
• for a period longer than one week
  

Ask a doctor before use if you have

noticed a sudden change in bowel habits that persist over a period of 2 weeks

When using this product

it may cause abdominal discomfort, faintness, rectal burning and mild cramps

Stop use and ask a doctor if

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

If pregnant or breast-feeding

ask a health professional before use.

Directions

• adults and children 12 years of age and older
• detach one suppository from the strip
• remove from wrapper before inserting into the rectum
• the rectal suppository dose is one suppository per day or as directed by a doctor
• children under 12 years of age consult a doctor

Other information

store below 30° C (86° F)

Inactive ingredient

hydrogenated vegetable oil

Manufactured for:
Akron Pharma Inc.,
Fairfield, NJ-07004
www.akronpharma.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ONELAX 
bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-8460
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	10 mg

Inactive Ingredients
Ingredient Name	Strength
FAT, HARD (UNII: 8334LX7S21)

Product Characteristics
Color	white (WHITE TO OFF WHITE)	Score
Shape	OVAL (TORPEDO SHAPE)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-8460-2	12 in 1 BOX	11/05/2021
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 71399-8460-5	50 in 1 BOX	11/05/2021
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	11/05/2021

Labeler - AKRON PHARMA INC (067878881)