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| Product NDC Code | 69846-140 | ||||
|---|---|---|---|---|---|
| Drug Name | Alophen |
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| Type | Brand | ||||
| Pharm Class | Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, COATED | ||||
| RxCUI drug identifier | 308753, 750171 |
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| Application Number | M007 | ||||
| Labeler Name | NUMARK BRANDS, INC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each enteric coated tablet) Purpose Bisacodyl 5 mg Laxative
| Bisacodyl 5 mg | Laxative |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
| 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 |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use for the relief of occasional constipation and irregularity. This product generally produces a bowel movement in 6-12 hours.
Purpose
Information about the drug product’s indications for use.Active ingredient (in each enteric coated tablet) Purpose Bisacodyl 5 mg Laxative
| Bisacodyl 5 mg | Laxative |
Spl product data elements
Usually a list of ingredients in a drug product.Alophen Bisacodyl 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 TCL;003 Carton Label
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have a sudden change in bowel habits over a period of 2 weeks.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? call 1-800-214-2379
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not chew the tablets it may cause abdominal discomfort, faintness, and cramps
Pregnancy or breast feeding
Pregnancy or Breast feedingAs with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at temperature not above 86° F(30 C)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API