Acetaminophen and pseudoephedrine

Name: Acetaminophen and pseudoephedrine

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about acetaminophen and pseudoephedrine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about acetaminophen and pseudoephedrine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using acetaminophen and pseudoephedrine.

Review Date: October 4, 2017

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.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling nervous and excitable.
  • Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

Usual Pediatric Dose for Sinus Symptoms

Infant drops (80 mg-7.5 mg/0.8 mL):
2 to 3 years or 24 to 35 lbs: 1.6 mL (2 droppersful) orally every 4 to 6 hours as needed, no more than four times a day.

Children's liquid (160 mg-15 mg/5 mL):
2 to 3 years or 24 to 35 lbs: 5 mL (1 teaspoonful) orally every 4 to 6 hours as needed, no more than four times a day.
4 to 5 years or 36 to 47 lbs: 7.5 mL (1 1/2 teaspoonsful) orally every 4 to 6 hours as needed, no more than four times a day.
6 to 8 years or 48 to 59 lbs: 10 mL (2 teaspoonsful) orally every 4 to 6 hours as needed, no more than four times a day.
9 to 10 years or 60 to 71 lbs: 12.5 mL (2 1/2 teaspoonsful) orally every 4 to 6 hours as needed, no more than four times a day.
11 years or 72 to 95 lbs: 15 mL (3 teaspoonsful) orally every 4 to 6 hours as needed, no more than four times a day.

Children's Chewable tablets (160 mg-15 mg):
2 to 5 years: 1 tablets orally every 4 to 6 hours as needed, no more than four times a day.
6 to 11 years: 2 tablets orally every 4 to 6 hours as needed, no more than four times a day.

Renal Dose Adjustments

Data not available

Use Labeled Indications

Sinus congestion/headache: Temporary relief of headache, sinus congestion and pressure, nasal congestion, and minor aches and pains

Contraindications

OTC labeling: When used for self-medication, do not use with any other drug containing acetaminophen; in combination with or within 14 days of stopping an MAOI.

Dosing Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Storage

Store at 15°C to 30°C (59°F to 86°F).

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