Adult Dosing
Analgesic, antipyretic, anti-inflammatory, decongestant
- 2 tabs [650 mg/15.6 mg] PO q4 hrs PRN
- Max: 8 tabs [2600 mg/62.4 mg]/day
Note:
- Dissolve tabs in 4 oz of water
Pediatric Dosing
Analgesic, antipyretic, anti-inflammatory, decongestant
- Children >12 yrs
- 2 tabs [650 mg/15.6 mg] PO q4 hrs PRN
- Max: 8 tabs [2600 mg/62.4 mg]/day
Note:
- Dissolve tabs in 4 oz of water
- Safety and effectiveness in pediatric patients <12 yrs have not been established
[Outline]
See Supplemental Patient Information
- Potential for development of Reye’s syndrome, a rare but serious illness, exists with aspirin; avoid use of this product in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. Advise patients/caregivers to consult a physician if they observe changes in behavior with nausea and vomiting during therapy
- Aspirin component of this combination drug may cause a severe allergic reaction including hives, facial swelling, asthma (wheezing), and shock
- NSAID component of this combination drug is associated with an increased risk of severe stomach bleeding; this risk is higher in patients
60yrs, having history of stomach ulcers or bleeding problems, receiving treatment with blood thinning agents (anticoagulant) or steroid drug, using other drugs containing prescription or nonprescription NSAIDs, consuming 3 alcoholic drinks/day, and those exceeding recommended dosages - Obtain a detailed medical history of patients for the presence of stomach/cardiovascular/renal/hepatic/respiratory/bleeding/thyroid/prostate disorders
- Aspirin component of this combination drug is associated with fetal harm and complications during delivery; avoid use of this combination drug in the last trimester of pregnancy unless it is deemed important to the mothers
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Hypertension
- Arrhythmias
- Diabetes mellitus
- GERD
- History of GI bleeding
- Peptic ulcer disease
- Prostatic hypertrophy
- Gout
- Hyperthyroidism
- Sodium-restricted diet
- Liver cirrhosis
- Angle-closure glaucoma
- Increased intracranial pressure
- Intracranial lesion
- PKU (phenylalanine-containing forms)
- Surgery or trauma
- Thrombocytopenia
- Patients <6 yrs
Supplemental Patient Information
- Instruct patients to inform their clinician if they are pregnant or breast-feeding prior to initiating therapy
- Advise patients to inform their clinician if they are being treated with any diuretic or receiving treatment for gout, diabetes, or arthritis
- Instruct patients to discontinue therapy and immediately consult their clinician on development of allergic reactions, signs of stomach bleeding, worsening or lasting of pain/nasal congestion for >1 wk, worsening or lasting of fever for >3 days, development of any new symptoms, tinnitus, deafness, nervousness, dizziness, or sleeplessness
Pregnancy Category:D aspirin; C phenylephrine
Breastfeeding: It is best to avoid aspirin during breastfeeding, especially with very young infants. As per some expert opinion, low dose aspirin (75-162 mg) may be used as an antiplatelet drug in nursing mothers; avoid chronic, high-dose aspirin. Avoid breastfeeding for 1-2 hours after a dose of aspirin to minimize antiplatelet effects in the infant. The risk of Reye's syndrome caused by salicylate in breastmilk is unknown. Phenylephrine is unlikely to reach the infant in large amounts, as the oral bioavailability of phenylephrine is only about 40%. However, oral administration of phenylephrine might decrease milk production. As no information is available on the use of oral phenylephrine during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 15 July 2011). Manufacturer advises to consult a physician before use in nursing mothers.
US Trade Name(s)
US Availability
Alka-Seltzer Plus Sinus (aspirin/phenylephrine)
- OTC Effervescent TABS: 325 mg/7.8 mg
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]