Acetaminophen, pheniramine, and phenylephrine

Name: Acetaminophen, pheniramine, and phenylephrine

For the Consumer

Applies to acetaminophen / pheniramine / phenylephrine: oral packet

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Not able to pass urine or change in how much urine is passed.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Usual Pediatric Dose for Cold Symptoms

Acetaminophen/pheniramine/phenylephrine 325 mg-20 mg-10 mg oral powder:
>=12 yrs: Dissolve 1 packet in 8 ounces of hot water and drink in 10 to 15 minutes. May repeat every 4 hours. Not to exceed 6 packets daily.

Acetaminophen/pheniramine/phenylephrine 650 mg-20 mg-10 mg oral powder:
>=12 yrs: Dissolve 1 packet in 8 ounces of hot water and drink in 10 to 15 minutes. May repeat every 4 hours. Not to exceed 6 packets daily.

Acetaminophen / pheniramine / phenylephrine Pregnancy Warnings

Acetaminophen/pheniramine/phenylephrine has not been formally assigned to a pregnancy category by the FDA. Acetaminophen has not been formally assigned to pregnancy category by the FDA. It is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Pheniramine has not been formally assigned to a pregnancy category by the FDA. There are no controlled data in human pregnancy. Phenylephrine has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Acetaminophen/pheniramine/phenylephrine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Acetaminophen / pheniramine / phenylephrine Breastfeeding Warnings

There are no data on the excretion of acetaminophen/pheniramine/phenylephrine into human milk. Acetaminophen is excreted into human milk in small concentrations. One case of a rash has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics. There are no data on the excretion of pheniramine into human milk. Small amounts of phenylephrine are secreted in breast milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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