Acetaminophen Phenyltoloxamine

Acetaminophen/phenyltoloxamine is an over-the-counter (OTC) product used for pain relief (analgesia).

Acetaminophen/phenyltoloxamine is available under the following different brand names: Phenagesic, AcetaGesic, Lagesic, PB Poly-650, Flextra DS, Phenylgesic, Relagesic Liquid, and Staflex.

Dosages of Acetaminophen/Phenyltoloxamine:

Dosage Forms and Strengths

Tablet

• 325mg/30mg
• 500mg/50mg
• 500mg/55mg
• 600mg/66mg
• 650mg/60mg

Dosage Considerations – Should be Given as Follows:

Analgesia

• Adults: 1-2 tablets or capsules orally every 4-6 hours as needed
• Products vary, see brand section and check specific labeling for each
• Safety and efficacy not established in pediatric patients

Common side effects of Acetaminophen/Phenyltoloxamine include:

• Skin swelling (angioedema)
• Throat swelling
• Sedation
• Itchy rash
• Hives
• Dry mouth
• Blood disorders (agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia)
• Thrombocytopenic purpura
• Liver toxicity
• Blurred vision
• Anaphylactoid reaction

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Acetaminophen/phenyltoloxamine has no listed severe interactions with other drugs.
• Acetaminophen/phenyltoloxamine has no listed serious interactions with other drugs.
• Acetaminophen/phenyltoloxamine has no listed moderate interactions with other drugs.
• Acetaminophen/phenyltoloxamine has no listed mild interactions with other drugs.

Warnings

• This medication contains acetaminophen/phenyltoloxamine. Do not take Phenagesic, AcetaGesic, Lagesic, PB Poly-650, Flextra DS, Phenylgesic, Relagesic Liquid, or Staflex if you are allergic to acetaminophen/phenyltoloxamine or any ingredients contained in this drug.

Contraindications

• Hypersensitivity to drugs or formulation components
• Hepatitis or severe hepatic/renal impairment

Effects of Drug Abuse

• No information is available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Acetaminophen/Phenyltoloxamine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Acetaminophen/Phenyltoloxamine?"

Cautions

• Caution in G6PD deficiency
• Consumption of 3 or more alcoholic beverages/day may increase the risk for liver damage (associated with acetaminophen)
• Do not take with other products that contain acetaminophen due to the risk of additive toxicity/overdose
• Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash
• May cause CNS depression and impair the ability to operate heavy machinery
• May cause hepatotoxicity in acute overdose
• Use caution in glaucoma, hepatic impairment, prostatic hyperplasia, respiratory disease, and renal impairment

Pregnancy and Lactation

• Use acetaminophen/phenyltoloxamine with caution during pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• Acetaminophen/phenyltoloxamine is excreted in breast milk.
• Pregnant or breastfeeding patients should seek the advice of a health professional before using over-the-counter (OTC) drugs.