Gentle Laxative by Healthlife of USA / Time Cap Laboratiries, Inc. GENTLE LAXATIVE tablet

Gentle Laxative by

Drug Labeling and Warnings

Gentle Laxative by is a Otc medication manufactured, distributed, or labeled by Healthlife of USA, Time Cap Laboratiries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Gentle Laxative 

Purpose 

Stimulant Laxative

Active Ingerient (in each tablet)

Bisacodyl 5mg

Uses

• For temporary relief of occasional constipation and irregularity
• This product generally produces a bowel movement in 6 to 12 hours

Warnings

Do not use

• If you cannot swallow without chewing

Ask a doctor before use if you have

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

When using this product

• Do not chew or crush tablet(s)
• Do not use within 1 hour after taking an antacid or milk 
• It may cause stomach discomfirt, faintness and cramps

Stop use and ask a doctor if

• you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition
• you need to use a laxative for more than 1 week

If pregnant or breast-feeding

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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

• Take with a glass of water 
• Adults and children 12 years of age and over : Take 1 to 3 tablets in a single daily dose
• Children 6 to under 12 years of age: Take 1 tablet in a single daily dose
• Children under 6 years of age: Ask a doctor

Other Information

• Store at controlled room temperature 20°- 25°C  (68°- 77°F)
• Read all product information before using 
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 

Inactive ingredients

• Colloidal silicon dioxide
• Croscarmellose sodium
• Dicalcium phosphate 
• FD&C Blue#1
• FD&C Blue#2
• Magnesium Stearate
• Microcrystalline cellulose
• Polyethylene glycol
• Polyvinyl alcohol
• Talc
• Titanium dioxide

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com

Gentle LaxativeBisacodyl 5 mgCompare to Dulcolax® Laxative active ingredients Distributed by: Healthlife of USA LLCRahwayNJ 07065www.healthlifeofusa.com

INGREDIENTS AND APPEARANCE

GENTLE LAXATIVE 
gentle laxative tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69517-116
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	5 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69517-116-24	1 in 1 CARTON	05/31/2017
1		24 in 1 BOTTLE; 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	05/31/2017

Labeler - Healthlife of USA (079656178)

Establishment
Name	Address	ID/FEI	Business Operations
Healthlife of USA		079656178	repack(69517-116)

Establishment
Name	Address	ID/FEI	Business Operations
Time Cap Laboratiries, Inc.		037052099	manufacture(69517-116) , pack(69517-116)