Norel SR Tablets

Generic name: acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride and phenyltoloxamine citrate
Dosage form: tablet, extended release
Drug class:Upper respiratory combinations

Medically reviewed by Drugs.com. Last updated on Apr 21, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DESCRIPTION
Each extended release tablet for oral administra- tion contains: Acetaminophen..... 325 mg Chlorpheniramine
Maleate ..... 8 mg Phenylephrine
HCl..... 40 mg Phenyltoloxamine
Citrate ..... 50 mg

CLINICAL PHARMACOLOGY
The mechanism of analgesic action of acetaminophen has not been fully deter- mined. Acetaminophen may act by inhibiting pro-staglandin synthesis in the central nervous system (CNS) and through peripheral action by blocking pain impulse generation. The peripheral action may also be due to inhibition of the synthesis of pro-staglandins or to inhibition of the synthesis or actions of other substances that sensitize pain receptors to mechanical or chemical stimulation.
Chlorpheniramine maleate is an alkylamine type anti-histamine. This group of antihistamines is among the most active histamine antagonists and are generally effective in relatively low doses.
Phenylephrine hydrochloride is primarily a direct acting sympathomimetic amine. Sympathomimetic amines act on alpha adrenergic receptors in the mucosa of the respiratory tract to produce vasoconstriction, which temporarily reduces the swelling associated with inflammation of the mucous membranes lining the nasal passages.
Phenyltoloxamine Citrate is an ethanol amine type compound used as an adjuvant with acetaminophen to mediate the release of bradykinin and pro-staglandin, two agents involved in the cause of inflammatory pain.

INDICATIONS AND USAGE
NOREL® SR is indicated for the temporary relief of allergy induced nasal congestion, runny nose, sneezing, headache and associated pain caused from inhalation of airborne antigens and other irritants.

CONTRAINDICATIONS
NOREL® SR should not be administered to patients who have previously exhibited hypersensitivity to any of the ingredients. Risk benefit should be considered when any of the following medical problems exist: