CONLAX- bisacodyl suppository

Conlax by

Drug Labeling and Warnings

Conlax by is a Otc medication manufactured, distributed, or labeled by Bliss GVS Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each suppository)

Bisacodyl USP, 10 mg

PURPOSE

Purpose

Stimulant Laxative

INDICATIONS & USAGE

Use

• for relief of occasional constipation (irregularity)
• this product generally produces a bowel movement in 15 minutes to 1 hour

WARNINGS

Warnings

For rectal use only

ASK DOCTOR

Ask a doctor before use if you have

• stomach pain, nausea or vomiting
• a sudden change in bowel habits that lasts more than 2 weeks

WHEN USING

When using this product you may experience stomach discomfort, faintness, rectal burning and mild cramps

STOP USE

Stop use and ask a doctor if

• you need to use a laxative product for longer than one week
• you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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.

DOSAGE & ADMINISTRATION

Directions

• adults and children 12 years of age and over:

  1 suppository in a single daily dose. Peel open plastic. Insert suppository

  well into rectum, pointed end first. Retain about 15 to 20 minutes.

• children 6 to under 12 years: 1/2 suppository in a single daily dose
• children under 6 years: Do not use

STORAGE AND HANDLING

Other information

• store at 20-25°C (68-77°F)
• if suppository softens prior to use, may be placed in refrigerator for short time

INACTIVE INGREDIENT

Inactive ingredient hard fat

QUESTIONS

Questions or Comments? 1-888-830-6075

OTHER SAFETY INFORMATION

TAMPER EVIDENT: DO NOT USE IF SEALED WRAPPER AROUND SUPPOSITORIES IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

Manufactured and Marketed by:

BLISS GVS PHARMA LTD.

102, Hyde Park, Saki Vihar Road,

Andheri (E), Mumbai - 400 072, INDIA

Email: info@blissgvs.com

www.blissgvs.com

PRINCIPAL DISPLAY PANEL

Bliss GVS

NDC: 72701-102-10

Conlax 10MG

Bisacodyl USP, 10 mg

Stimulant Laxative

Gentle, Predictable, Fast Relief

10 suppositories

DO NOT SWALLOW

INGREDIENTS AND APPEARANCE

CONLAX 
bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72701-102
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	Score
Shape	BULLET	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72701-102-10	2 in 1 CARTON	12/16/2018
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 72701-102-05	20 in 1 CARTON	12/16/2018
2		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 72701-102-04	1 in 1 CARTON	12/16/2018
3		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 72701-102-08	2 in 1 CARTON	12/16/2018
4		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 72701-102-12	3 in 1 CARTON	12/16/2018
5		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 72701-102-16	4 in 1 CARTON	12/16/2018
6		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC: 72701-102-28	7 in 1 CARTON	12/16/2018
7		4 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	12/16/2018

Labeler - Bliss GVS Pharma Limited (675629890)

Establishment
Name	Address	ID/FEI	Business Operations
Bliss GVS Pharma Limited		675630493	manufacture(72701-102) , analysis(72701-102) , label(72701-102) , pack(72701-102)