Dosage and administration
do not chew tablets adults and children 12 years of age and over 1-3 tablets in a single daily dose children 6 to under 12 years of age 1 tablet in a single daily dose children under 6 years of age consult a doctor
Alophen
- Manufacturer
- NUMARK BRANDS, INC
- Effective date
- 2023-12-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:17:43
Label at a glance#
ProductAlophen
Active ingredientBisacodyl
Label structure13 sections
Storage and handling
store at temperature not above 86° F(30 C)
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredient (in each enteric coated tablet) | Purpose |
| Bisacodyl 5 mg | Laxative |
Use
for the relief of occasional constipation and irregularity. This product generally produces a bowel movement in 6-12 hours.
Warnings
Do not use
- unless directed by a doctor, when abdominal pain, nausea, or vomiting are present
- this product for more than 1 week unless directed by a doctor
- this product within 1 hour after taking an antacid or milk
- for children under 6 years of age
- for persons who can not swallow without chewing
Ask a doctor before use if you have
a sudden change in bowel habits over a period of 2 weeks.
When using this product
- do not chew the tablets
- it may cause abdominal discomfort, faintness, and cramps
Stop use and ask a doctor if
- rectal bleeding occurs
- there is failure to have a bowel movement after use of a laxative. These may indicate a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not chew tablets
| adults and children 12 years of age and over | 1-3 tablets in a single daily dose |
| children 6 to under 12 years of age | 1 tablet in a single daily dose |
| children under 6 years of age | consult a doctor |
Other information
store at temperature not above 86° F(30 C)
Inactive ingredients
acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate
Questions?
call 1-800-214-2379
PRINCIPAL DISPLAY PANEL
NDC 69846-140-01
Now Smaller,
Easier to Swallow
Alophen®
(Bisacodyl USP)
Comfort Coated
Stimulant Laxative
Gentle, Effective
Overnight Relief
100 Tablets, 5 mg. each
Do not use if printed "SEALED FOR YOUR PROTECTION" inner seal is broken or missing.
Dist. by: Numark Brands, Inc. 57001
EDISON, NJ 08818 1-800-214-2379 Rev. 4/21
LOT #
EXP. DATE
NDC 69846-140-01
Now Smaller, Easier to Swallow
Alophen®
(Bisacodyl USP)
Comfort Coated
Stimulant Laxative
Gentle, Effective
Overnight Relief
100 Tablets, 5 mg. each
REFER TO OUTER CARTON FOR FULL INFORMATION
Distributed by: Numark Brands, Inc.
EDISON, NJ 08818 1-800-214-2379 57000 Rev. 1/21
LOT #
EXP. DATE
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69846-140-01 | EA - Each | 69846-140 | bd87fb34-d562-44de-95c6-faca5b7aedc0 | 1 | 2021-03-02 |
Products#
Every source-derived product name is available through these pages.
- Alophen
- Bisacodyl
- Deacetylbisacodyl
- Acacia
- Ammonia
- Calcium Carbonate
- Carnauba Wax
- Silicon Dioxide
- Starch, Corn
- D&C Yellow No. 10
- Fd&C Yellow No. 6
- Hypromellose, Unspecified
- Ferrosoferric Oxide
- Anhydrous Lactose
- Magnesium Stearate
- Methylparaben
- Polydextrose
- Polyethylene Glycol, Unspecified
- Polyvinyl Acetate Phthalate
- Povidone, Unspecified
- Propylene Glycol
- Propylparaben
- Shellac
- Dimethicone
- Sodium Alginate
- Sodium Benzoate
- Sodium Bicarbonate
- Stearic Acid
- Sucrose
- Talc
- Titanium Dioxide
- Triacetin
- Triethyl Citrate
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69846-140 | 69846-140-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9faaaa26-db8a-445d-9740-5055cd186b43 | 622fda65-cead-ae70-0f7d-b202d49192af | 2023-12-18 | Warnings | 9faaaa26-db8a-445d-9740-5055cd186b43 622fda65-cead-ae70-0f7d-b202d49192af |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.