Acetaminophen and Pseudoephedrine

(a seet a MIN oh fen & soo doe e FED rin)

Dosage Forms

• This medicine is available as a caplet.

Pharmacologic Category

• Alpha/Beta Agonist
• Analgesic, Miscellaneous

What key warnings should I know about before giving this medicine to my child?

• Talk with healthcare provider before giving this medicine to a child. Check all of your child's medicines, including over-the-counter, with healthcare provider.
• This medicine does not mix well with many medicines. Serious reactions may occur. Check all medicines with child's healthcare provider.

Is it safe for my child to take this medicine?

• Not if your child has an allergy to acetaminophen, pseudoephedrine, or any other part of this medicine.
• Be sure to let healthcare provider know if your child has any allergies or reactions to medicine, food preservatives, or dyes. Make sure to tell about the allergy and how it affected your child. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.

Why does my child need this medicine?

• This medicine is used to relieve pain.
• This medicine is used to treat nasal congestion.

How does this medicine work?

• Acetaminophen blocks production and release of chemicals that cause pain.
• Pseudoephedrine shrinks swollen nasal tissue and opens up passages.

How is this medicine given?

• Do not give more than prescribed amount. Liver damage can occur.
• Give this medicine with or without food. Give with food if it causes an upset stomach.

How long does this medicine take to work?

• Your child may start feeling better soon after starting this medicine.

What do I do if my child misses a dose? (does not apply to patients in the hospital)

• Give a missed dose as soon as possible.
• If it is almost time for the next dose, skip the missed dose and return to your child's regular schedule.
• Do not give a double dose or extra doses.
• Many times this medicine is given on an as needed basis.

What safety measures should I take while my child is using this medicine?

• Avoid giving your child other sources of acetaminophen. An overdose may cause dangerous problems.
• Read package labeling carefully; make sure you have the correct concentration of the product your child needs.
• If your child has diabetes, talk with healthcare provider.
• If your child has heart disease, talk with healthcare provider.
• If your child has high blood pressure, talk with healthcare provider.
• If your child has liver disease, talk with healthcare provider.
• If your child has thyroid disease, talk with healthcare provider.
• Be careful if your child has G6PD deficiency. Anemia may occur.
• Check your child's medicines with healthcare provider. This medicine may not mix well with other medicines.
• Avoid giving your child other medicines and natural products that slow actions and reactions.
• Limit your child's caffeine and chocolate intake. Use with this medicine may cause nervousness, shakiness, and fast heartbeat.

What are some possible side effects of this medicine?

• Nervous and excitable.
• Dry mouth. Frequent mouth care may help. Older children may suck hard, sugar-free candy.
• Inability to sleep.
• Liver damage can rarely occur.

What should I monitor?

• Change in condition being treated. Is it better, worse, or about the same?
• For the occurrence of side effects.
• Dry mouth may cause an increase in cavities. Take good care of your child's teeth. See a dentist regularly.

When should I call my child's healthcare provider?

• If any of this information causes you to be concerned, any of the common side effects occur, or if your child's symptoms do not improve after taking this medicine.
• If you suspect an overdose, call your local poison control center or emergency department immediately.
• If your child shows signs of a life-threatening reaction, call healthcare provider or emergency department immediately. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; swelling of face, lips, tongue, or throat; or if your child exhibits any other unusual behavior.
• If your child is feeling extremely nervous and excitable.
• If your child has dark urine or yellow skin or eyes.
• If your child develops a rash.
• No improvement in condition or if you believe your child's condition is worse.

How should I store and/or dispose of this medicine?

• Store at room temperature.
• Protect from moisture. Do not store in a bathroom or kitchen.

General statements

• If your child has a life-threatening allergy, he/she should wear an allergy identification bracelet at all times.
• This medicine is available without a prescription.
• This medicine should be thrown out when your child no longer needs it or if the medicine becomes outdated.
• Do not share your child's medicine with others and do not give anyone else's medicine to your child.
• Keep all medicine out of the reach of children and pets.
• Many medications interact with other medications. Keep a list of all your child's medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to your child's healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).
• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or in Canada to Health Canada's Canada Vigilance Program at 1-866-234-2345.
• Talk with your child's healthcare provider before giving him/her any new medicine, including over-the-counter, natural products, or vitamins.
• Medicine can be dangerous if used incorrectly. Follow directions given by healthcare provider.

Copyright © 1978- Lexi-Comp Inc., The Children's Hospital, Denver, CO., and Pediatric Pharmacy Advocacy Group, Inc. All Rights Reserved. This information is protected under US and international copyright law. Unauthorized use or reproduction is prohibited.

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