Laxomil (hhh)

Laxomil (hhh)
SPL v1
SPL
SPL Set ID 3999935b-d8e8-52a6-e063-6294a90aa2a2
Route
ORAL
Published
Effective Date 2025-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromellose, Unspecified Magnesium Stearate Polyethylene Glycol, Unspecified Talc Titanium Dioxide Silicon Dioxide Water Methacrylic Acid Maltodextrin Microcrystalline Cellulose Sodium Starch Glycolate Type A Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: B5 Shape: round Color: orange Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-10

Description

Active ingredientes (in each tablet) Purpose Bisacodyl 5 mg ......... Stimulant laxative


Medication Information

Description

Active ingredientes (in each tablet) Purpose Bisacodyl 5 mg ......... Stimulant laxative

Use

For relief of occasional constipation (irregularity). This product generally produces bowel movement in 6 to 12 hours.

Section 51945-4

Section 55105-1
Active ingredientes (in each tablet) Purpose
Bisacodyl 5 mg ......... Stimulant laxative

Directions
  • take with plenty of water
  • do not chew or crush tablet(s)
Age Dose
adults and children 12 years and older take 1 to 3 tablets in a single dose, once a day
children 6 to undee 12 years take 1 tablet once a day
children under 6 years consult a doctor

Do Not Use
  • if you cannot swallow without chewing. These tablets should not be chewed because gastric irritation may occur.
Questions?

+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com

Dist. By/ Por:

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

www.pharmadel.com

Other Information
  • store between 68-77°F (20-25°C)
  • do not use if seal under cap is torn, broken or missing
Inactive Ingredients

D&C yellow #10, FD&C yellow #6, hypromellose, magnesium stearate, maltodextrin, methacrylic acid, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium starch glycolate type A, talc, titanium dioxide,triethyl citrate, water

When Using This Product
  • take this product 2 hours before or after other drugs
  • do not take this product within 1 hour after taking an antacid or milk
Stop Use and Ask A Doctor If
  • you need to use for more than 7 days
  • rectal bleeding occurs
  • you fail to have a bowel movement after use of a laxative. This may indicate a serious condition.
Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use

Ask A Doctor Before Use If You Have
  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

Structured Label Content

Use

For relief of occasional constipation (irregularity). This product generally produces bowel movement in 6 to 12 hours.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)
Active ingredientes (in each tablet) Purpose
Bisacodyl 5 mg ......... Stimulant laxative

Directions
  • take with plenty of water
  • do not chew or crush tablet(s)
Age Dose
adults and children 12 years and older take 1 to 3 tablets in a single dose, once a day
children 6 to undee 12 years take 1 tablet once a day
children under 6 years consult a doctor

Do Not Use (Do not use)
  • if you cannot swallow without chewing. These tablets should not be chewed because gastric irritation may occur.
Questions?

+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com

Dist. By/ Por: (Dist. by/ por:)

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

www.pharmadel.com

Other Information (Other information)
  • store between 68-77°F (20-25°C)
  • do not use if seal under cap is torn, broken or missing
Inactive Ingredients (Inactive ingredients)

D&C yellow #10, FD&C yellow #6, hypromellose, magnesium stearate, maltodextrin, methacrylic acid, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium starch glycolate type A, talc, titanium dioxide,triethyl citrate, water

When Using This Product (When using this product)
  • take this product 2 hours before or after other drugs
  • do not take this product within 1 hour after taking an antacid or milk
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you need to use for more than 7 days
  • rectal bleeding occurs
  • you fail to have a bowel movement after use of a laxative. This may indicate a serious condition.
Keep Out of Reach of Children (Keep out of reach of children)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)