GOOD REMEDIES GENTLE LAXATIVE- bisacodyl tablet, coated

GOOD REMEDIES GENTLE Laxative by

Drug Labeling and Warnings

GOOD REMEDIES GENTLE Laxative by is a Otc medication manufactured, distributed, or labeled by Strive Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Bisacodyl (USP) 5 mg

Purpose

Stimulant laxative

Use

for relief of occasional constipation and irregularity this product generally produces bowel movement in 6-12 hours

Warnings

Do not use if you cannot swallow without chewing.

Ask a doctor before use if you have
stomach pain, nausea or vomiting
noticed a sudden change in bowel habits that lasts more than 2 weeks

When using this product
it may cause stomach discomfort, faintness and cramps do not chew or crush tablet(s) do not use within 1 hour after taking an antacid or milk

Stop use and ask a doctor if
you have rectal bleeding or fail to have a 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.

Directions

do not take more than directed
take with a glass of water

• adults and children 12 years of age and over: 1 to 3 tablets in a single daily dose. It is recommended to start with the lowest dose (1 tablet) increasing the next day as needed
• children 6 to under 12 years of age: 1 tablet in a single daily dose
• children under 6 years: ask a doctor

Other information

contains FD&C yellow no. 6
store at 20°C- 25°C (68°-77°F)
protect from excessive humidity

Inactive ingredients

acacia gum, calcium carbonate, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate, FD&C yellow #6 aluminum lake, gelatin, glycerol monostearate, hypromellose, iron oxide red, magnesium stearate, methacrylic acid co-polymer type C, microcrystalline cellulose, polyethylene glycol, precipitated silica, silicon dioxide, sodium methylparaben, sodium propylparaben, sodium starch glycolate, starch, sucrose, talcum, titanium dioxide, triethyl citrate

Questions or comments?

1-888-577-8033 Monday-Friday 8am - 4pm EST

SPL UNCLASSIFIED SECTION

Compare to the active ingredient of Dulcolax® Laxative Tablets*

Gentle, dependable constipation relief

*This product is not manufactured or distributed by Sanofi-Aventis Deutschland GMBH, owner of the registered trademark Dulcolax® Laxative Tablets.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

DISTRIBUTED BY:
Strive Pharmaceuticals, Inc.
East Brunswick, NJ 08816

Product of India

CT7069216752    REV.00-072023

Packaging

INGREDIENTS AND APPEARANCE

GOOD REMEDIES GENTLE LAXATIVE 
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70692-167
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
ACACIA (UNII: 5C5403N26O)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	G
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70692-167-52	1 in 1 CARTON	11/10/2023
1		25 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 Drug	505G(a)(3)	11/10/2023

Labeler - Strive Pharmaceuticals Inc. (080028013)