[Beutlich Pharmaceuticals, LLC]
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph not final|
- for relief of occasional constipation
- this product generally produces a bowel movement in 5 to 30 minutes
Keep out of reach of children
If swallowed, get medical help or contact a poison control center right away
Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
Do not use this product if you are on a low salt diet unless directed by a doctor
Do not lubricate with mineral oil or petrolatum prior to rectal insertion
If you have noticed a sudden change in bowel habits that persists over a period of 2 weeks, consult a doctor before using a laxative
Laxative products should not be used for a period longer than 1 week unless directed by a doctor
Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a serious condition. Discontinue use and consult your doctor.
Adults and children 12 years of age and over: rectal dosage is one suppository containing 0.6 gram of sodium bicarbonate and 0.9 gram of potassium bitartrate in a single daily dose
Children under 12 years of age: consult a doctor
Detach one suppository from the strip; remove plastic wrapper. Moisten suppository by placing it under a water tap for 30 seconds, or in a cup of water for at least 10 seconds, before insertion. Insert rectally, bulb shape first, past largest diameter of suppository. Retain suppository as long as possible (usually 10 to 30 minutes) before defecating.
- store at 20-25 ºC (68-77 ºF). Do not exceed 30 ºC (86 ºF).
- do not refrigerate
- for your protection, suppositories are individually wrapped in tamper-resistant film. Do not use if film is torn or open when purchased.
- save this carton for future reference
|Labeler - Beutlich Pharmaceuticals, LLC (005209325)|
|Registrant - Beutlich Pharmaceuticals, LLC (005209325)|
|Beutlich Pharmaceuticals, LLC||005209325||repack(0283-0808)|