Acetaminophen/Doxylamine/Dextromethorphan/Phenylephrine

Acetaminophen/doxylamine/dextromethorphan/phenylephrine is an over-the-counter (OTC) product used for congestion, runny nose, cough, sore throat, headache, fever, and minor aches and pains.

Acetaminophen/doxylamine/dextromethorphan/phenylephrine is available under the following different brand names: Alka-Seltzer Plus Night Cold Formula, Tylenol Cold Multi-Symptom Nighttime Liquid, Alka-Seltzer Plus Night Severe Cold, Cough & Flu, and Alka-Seltzer Plus Night Sinus Congestion, Allergy & Cough.

Dosages of Acetaminophen/Doxylamine/Dextromethorphan/Phenylephrine:

Dosage Forms and Strengths

Capsule

• 325mg/6.25mg/10mg/5mg

Dosage Considerations – Should be Given as Follows:

Congestion, Rhinorrhea, Cough, Sore Throat, Headache, Fever, Minor Aches & Pains

• Adults and children 12 years and older: 2 caps orally every 4 hours as needed; not to exceed 12 caps/day
• Children under 12 years: Ask a pediatrician

Side effects of acetaminophen/doxylamine/dextromethorphan/phenylephrine include:

• High blood pressure (hypertension)
• Fast heart rate
• Severe peripheral and visceral vasoconstriction
• Dizziness
• Drowsiness
• Excitability
• Headache
• Restlessness
• Tremor
• Skin rash
• Gastrointestinal disturbances
• Anemia
• Blood disorders (neutropenia, pancytopenia, leukopenia)
• Increased bilirubin and alkaline phosphatase
• Dry mouth, throat, and nose
• Thickening of mucus in nose or throat

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

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Severe interactions of acetaminophen/doxylamine/dextromethorphan/phenylephrine include:
  • isocarboxazid
  • phenelzine
  • procarbazine
  • rasagiline
  • safinamide
  • selegiline
  • tranylcypromine
• Acetaminophen/doxylamine/dextromethorphan/phenylephrine has serious interactions with at least 43 different drugs.
• Acetaminophen/doxylamine/dextromethorphan/phenylephrine has moderate interactions with at least 226 different drugs.
• Acetaminophen/doxylamine/dextromethorphan/phenylephrine has mild interactions with at least 76 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/doxylamine/dextromethorphan/phenylephrine. Do not take Alka-Seltzer Plus Night Cold Formula, Tylenol Cold Multi-Symptom Nighttime Liquid, Alka-Seltzer Plus Night Severe Cold, Cough & Flu, or Alka-Seltzer Plus Night Sinus Congestion, Allergy & Cough if you are allergic to acetaminophen/doxylamine/dextromethorphan/phenylephrine or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity
• Asthma
• Narrow-angle glaucoma
• Symptomatic prostate hypertrophy
• Bladder-neck obstruction
• Stenosing peptic ulcer
• G-6-PD deficiency
• Severe hepatic impairment

Effects of Drug Abuse

• No information is available

Short-Term Effects

• See "What Are Side Effects Associated with Using Acetaminophen/Doxylamine/Dextromethorphan/Phenylephrine?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Acetaminophen/Doxylamine/Dextromethorphan/Phenylephrine?”

Cautions

• Acetaminophen hepatotoxicity is possible in chronic alcoholics following various dose levels; severe or recurrent pain or high or continued fever may indicate a serious illness
• Acetaminophen contained in many over-the-counter (OTC) products and combined use with these products may result in toxicity due to cumulative doses exceeding recommended maximum dose
• Do not take dextromethorphan for persistent or chronic cough associated with smoking, asthma, or emphysema, or if it is accompanied by excessive phlegm unless directed by a healthcare provider
• Dextromethorphan may slow respiration rate
• Doxylamine may exacerbate angle-closure glaucoma, hyperthyroidism, peptic ulcer, or urinary tract obstruction; dry mouth may occur

Pregnancy and Lactation

• Use acetaminophen/doxylamine/dextromethorphan/phenylephrine 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/doxylamine/dextromethorphan/phenylephrine is excreted in breast milk. Use caution while breastfeeding.
• Pregnant or breastfeeding patients should seek the advice of a health professional before using over-the-counter (OTC) drugs.