Acetaminophen Diphenhydramine Dextromethorphan

Acetaminophen/diphenhydramine/dextromethorphan is an over-the-counter (OTC) product used for the relief of cold and flu symptoms.

Acetaminophen/diphenhydramine/dextromethorphan is available under the following different brand names: Diabetic Tussin Nighttime Cold & Flu.

Dosages of Acetaminophen/Diphenhydramine/Dextromethorphan:

Oral Solution

• (325mg/12.5mg/10mg)/5mL

Dosage Considerations – Should be Given as Follows:

Cold and Flu

• Indicated for the relief of cold and flu symptoms
• Adults and children over 12 years: 10 mL orally every 4 hours as needed; not to exceed 6 doses/24 hours
• Children 6-12 years: 5 mL orally every 4 hours as needed; not to exceed 6 doses/24 hours
• Children under 6 years: Safety and efficacy not established

• Pediatric

• Based on acetaminophen component: 10-15 mg/kg/dose orally every 4-6 hours as needed; not to exceed 5 doses/24 hours

Common side effects of Acetaminophen/Diphenhydramine/Dextromethorphan include:

• Nausea
• Vomiting
• Thick sputum
• Constipation
• Drowsiness
• Dizziness
• Sedation
• Blurred vision
• Involuntary eye movement (nystagmus)

Less common side effects of acetaminophen/diphenhydramine/dextromethorphan include:

• Angioedema
• Throat swelling
• Disorientation
• Dizziness
• Drowsiness
• Confusion
• Decreased cognitive function in elderly
• Itching rash
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Hives
• blood disorders (agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia)
• Thrombocytopenic purpura
• Liver toxicity
• Liver failure
• Gastrointestinal bleeding
• Kidney toxicity
• Pneumonitis
• Anaphylactoid reactions
• Anticholinergic effects
• Dry mouth/nose/throat

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

• Severe interactions of Acetaminophen Dextromethorphan Phenylephrine include:
  • eliglustat
  • isocarboxazid
• Acetaminophen/diphenhydramine/dextromethorphan has serious interactions with at least 36 different drugs.
• Acetaminophen/diphenhydramine/dextromethorphan has moderate interactions with at least 328 different drugs.
• Acetaminophen/diphenhydramine/dextromethorphan has mild interactions with at least 102 different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains acetaminophen/diphenhydramine/dextromethorphan. Do not take Diabetic Tussin Nighttime Cold & Flu if you are allergic to acetaminophen/diphenhydramine/dextromethorphan or any ingredients contained in this drug.

Contraindications

• Hypersensitivity
• Hepatitis or hepatic/renal dysfunction, alcoholism
• Repeated administration in patients with anemia or cardiac, pulmonary, or renal disease
• Use within 14 days of monoamine oxidase inhibitor (MAOI) therapy
• Lower respiratory disease, e.g., asthma (controversial)
• Premature newborns and neonates
• Nursing women

Effects of Drug Abuse

• No information is available.

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Acetaminophen is found in many other dosage forms and products, check the label carefully to avoid 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
• The risk of hepatotoxicity is higher in alcoholics or with the use of more than one acetaminophen-containing product
• G6PD deficiency
• Phenylketonuria (the phenylalanine in orange flavoring)
• Driving or operating machinery
• Avoid alcohol
• Caution in narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction

Pregnancy and Lactation

• Acetaminophen and diphenhydramine may be acceptable for use during pregnancy. Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk.
• Use dextromethorphan 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 is excreted in breast milk but is compatible with breastfeeding.
• Diphenhydramine enters breast milk and is contraindicated for use while breastfeeding.
• It is unknown if dextromethorphan is excreted in breast milk. Use caution while breastfeeding.