phenylephrine hydrochloride

FDA Drug Profile — Phenylephrine Hydrochloride, Equate Nasal, phenylephrine hydrochloride, Phenylephrine hydrochloride, PHENYLEPHRINE HYDROCHLORIDE

phenylephrine hydrochloride is listed in the FDA National Drug Code directory with 20 NDC codes, marketed under brand names including Phenylephrine Hydrochloride, Equate Nasal, phenylephrine hydrochloride. Available dosage forms: solution/ drops, spray, injection, tablet, film coated.

Drug Details

Generic Name
phenylephrine hydrochloride
Brand Names
Phenylephrine Hydrochloride, Equate Nasal, phenylephrine hydrochloride, Phenylephrine hydrochloride, PHENYLEPHRINE HYDROCHLORIDE, Crane Safety Sinus Decongestant, NO DRIP NASAL
Application Number
NDA203510
Sponsor
Bausch & Lomb Americas Inc.
NDC Codes
20
Dosage Forms
SOLUTION/ DROPS, SPRAY, INJECTION, TABLET, FILM COATED
Routes
OPHTHALMIC, NASAL, INTRAVENOUS, ORAL
Active Ingredients
PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses • for the temporary relief of: • local itching and discomfort associated with hemorrhoids • burning • pain • soreness • temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders. • temporarily shrinks hemorrhoidal tissue.

Warnings

Warnings For external use only Allergy alert : certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor. Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland 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 • do not exceed the recommended daily dosage unless directed by a doctor. • do not put this product into the rectum by using fingers or any mechanical device or applicator. • in case of bleeding, consult a doctor promptly. Stop use and ask a doctor if • condition worsens or does not improve within 7 days. • an allergic reaction develops. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.