Acetaminophen, diphenhydramine, and phenylephrine

Name: Acetaminophen, diphenhydramine, and phenylephrine

What should I discuss with my healthcare provider before taking this medicine?

You should not use this medication if you are allergic to acetaminophen, diphenhydramine, or phenylephrine.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

  • asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

  • a blockage in your stomach or intestines;

  • liver disease, alcoholism, or if you drink more than 3 alcoholic beverages per day;

  • kidney disease;

  • high blood pressure, heart disease, coronary artery disease, or recent heart attack;

  • enlarged prostate or urination problems;

  • glaucoma;

  • diabetes;

  • overactive thyroid;

  • pheochromocytoma (an adrenal gland tumor); or

  • if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

It is not known whether acetaminophen, diphenhydramine, and phenylephrine will harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant.

This medication may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without your doctor's advice if you are breast-feeding a baby.

Acetaminophen, diphenhydramine, and phenylephrine dosing information

Usual Adult Dose for Cold Symptoms:

Acetaminophen/diphenhydramine/phenylephrine 325 mg-12.5 mg-5 mg oral tablet, or
Acetaminophen/diphenhydramine/phenylephrine 325 mg-25 mg-5 mg oral tablet:
2 tablets orally every 4 hours not to exceed 12 tablets daily.

Acetaminophen/diphenhydramine/phenylephrine 325 mg-12.5 mg-5 mg/15 mL oral syrup:
30 mL orally every 4 hours not to exceed 180 mL daily.

Acetaminophen/diphenhydramine/phenylephrine 650 mg-25 mg-10 mg oral powder for reconstitution (one packet):
one packet dissolved in 8 oz hot water orally every 4 hours; sip while hot. Consume entire drink within 10 to 15 minutes. Do not exceed 6 packets in 24 hours.

Acetaminophen/diphenhydramine/phenylephrine 160 mg-6.25 mg-2.5 mg/5 mL oral liquid:
20 mL orally every 4 hours not to exceed 6 doses in any 24 hour period.
Acetaminophen/diphenhydramine/phenylephrine 325 mg-12.5 mg-5 mg/10 mL oral liquid:
20 mL orally every 4 hours not to exceed 6 doses in any 24 hour period.
Acetaminophen/diphenhydramine/phenylephrine 650 mg-25 mg-10 mg/20 mL oral liquid:
20 mL orally every 4 hours not to exceed 6 doses in any 24 hour period.

Usual Pediatric Dose for Cold Symptoms:

Acetaminophen/diphenhydramine/phenylephrine 325 mg-12.5 mg-5 mg oral tablet:
12 yrs or older: 2 tablets orally every 4 hours not to exceed 12 tablets daily.
6 yrs to 11 yrs: 1 tablet orally every 4 hours not to exceed 5 tablets daily.

Acetaminophen/diphenhydramine/phenylephrine 325 mg-25 mg-5 mg oral tablet:
12 yrs or older: 2 tablets orally every 4 hours not to exceed 12 tablets daily.

Acetaminophen/diphenhydramine/phenylephrine 325 mg-12.5 mg-5 mg/15 mL oral syrup
12 yrs or older: 30 mL orally every 4 hours not to exceed 180 mL daily.

Acetaminophen/diphenhydramine/phenylephrine 650 mg-25 mg-10 mg oral powder for reconstitution (one packet):
12 yrs or older: one packet dissolved in 8 oz hot water orally every 4 hours; sip while hot. Consume entire drink within 10 to 15 minutes. Do not exceed 6 packets in 24 hours.

Acetaminophen/diphenhydramine/phenylephrine 160 mg-6.25 mg-2.5 mg/5 mL oral liquid:
12 yrs or older: 20 mL orally every 4 hours not to exceed 6 doses in any 24 hour period.
Acetaminophen/diphenhydramine/phenylephrine 325 mg-12.5 mg-5 mg/10 mL oral liquid:
12 years or older: 20 mL orally every 4 hours not to exceed 6 doses in any 24 hour period.
6 years to under 12 years of age: 10 mL every 4 hours not to exceed 5 doses in any 24 hour period.
Acetaminophen/diphenhydramine/phenylephrine 650 mg-25 mg-10 mg/20 mL oral liquid:
12 years or older: 20 mL orally every 4 hours not to exceed 6 doses in any 24 hour period.

What other drugs will affect this medicine?

Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking acetaminophen, diphenhydramine, and phenylephrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

For the Consumer

Applies to acetaminophen / diphenhydramine / phenylephrine: oral liquid, oral packet, oral suspension, oral tablet

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.
  • Feeling sleepy.

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.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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