phenylephrine hydrochloride

FDA Drug Profile — Phenylephrine hydrochloride, Equate Nasal, PHENYLEPHRINE HYDROCHLORIDE, Phenylephrine Hydrochloride, Crane Safety Sinus Decongestant

Drug Details

Generic Name
phenylephrine hydrochloride
Brand Names
Phenylephrine hydrochloride, Equate Nasal, PHENYLEPHRINE HYDROCHLORIDE, Phenylephrine Hydrochloride, Crane Safety Sinus Decongestant, phenylephrine hydrochloride
Application Number
ANDA217069
Sponsor
Lifestar Pharma LLC
NDC Codes
19
Dosage Forms
INJECTION, SPRAY, SOLUTION/ DROPS, TABLET, FILM COATED
Routes
INTRAVENOUS, NASAL, OPHTHALMIC, ORAL
Active Ingredients
PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses: Helps relieve the local itching and discomfort in the perianal area. Temporarily relieves pain, irritation or burning and reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders.

Warnings

Warnings: For external use only. Allergy alert • Certain persons can develop allergic reactions to ingredients in this product. Do not Exceed the recommended daily dosage unless directed by a doctor. Put this product into the rectum by using fingers or any mechanical device or applicator. Use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. Ask a doctor or pharmacist before use if you are Presently taking a prescription drug for high blood pressure or depression. When using this product If condition worsens or does not improve within 7 days, consult a doctor. In case of bleeding, consult a doctor promptly. Stop use and ask a doctor if If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away. If pregnant or breastfeeding, ask a health professional before use.