Sudafed Pe Severe Cold Generic Name & Formulations
Legal Class
OTC
General Description
Acetaminophen 325mg, diphenhydramine HCl 12.5mg, phenylephrine HCl 5mg; per caplet.
Pharmacological Class
Analgesic + antihistamine + sympathomimetic.
How Supplied
Severe Cold—12, 24
Manufacturer
Sudafed Pe Severe Cold Indications
Indications
Nasal congestion, rhinorrhea, headache, sore throat, fever.
Sudafed Pe Severe Cold Dosage and Administration
Adult
2 caplets every 4hrs as needed; max 12 caplets/24hrs.
Children
<6yrs: individualize. 6–11yrs: 1 caplet every 4hrs as needed; max 5 caplets/24hrs.
Sudafed Pe Severe Cold Contraindications
Contraindications
Within 14 days of MAOIs. Concomitant acetaminophen or diphenhydramine (including topical) products.
Sudafed Pe Severe Cold Boxed Warnings
Not Applicable
Sudafed Pe Severe Cold Warnings/Precautions
Warnings/Precautions
Cardiovascular disease. Hypertension. Liver disease. Thyroid disease. Glaucoma. Diabetes. Asthma. Lower respiratory disorders. GI or GU obstruction.
Sudafed Pe Severe Cold Pharmacokinetics
See Literature
Sudafed Pe Severe Cold Interactions
Interactions
See Contraindications. Increased risk of liver damage with ≥3 alcoholic drinks/day. Hypertensive crisis with MAOIs. β-blockers may increase the pressor effects of sympathomimetics. Other CNS depressants potentiated. Antihypertensives antagonized.
Sudafed Pe Severe Cold Adverse Reactions
Adverse Reactions
Drowsiness, anticholinergic effects, nervousness, dizziness, insomnia, excitability in children.
Sudafed Pe Severe Cold Clinical Trials
See Literature
Sudafed Pe Severe Cold Note
Not Applicable
Sudafed Pe Severe Cold Patient Counseling
See Literature