FDA Label for Alophen
View Indications, Usage & Precautions
Alophen Product Label
The following document was submitted to the FDA by the labeler of this product Numark Brands, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
| Active ingredient (in each enteric coated tablet) | Purpose |
| Bisacodyl | 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
- 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
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, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10, FD&C Yellow #6, gelatin, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl acetate phthalate, povidone, pharmaceutical glaze, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide
Questions?
call 1-800-331-0221
Principal Display Panel
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 LABORATORIES INC.
EDISON, NJ 08818 Rev. 3/12 57001
LOT #
EXP. DATE
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 LABORATORIES INC.
EDISON, NJ 08818 Rev. 3/12 57000
LOT #
EXP. DATE
* Please review the disclaimer below.