Adult Dosing
Common cold and other upper respiratory allergies
- 2 tabs PO q4 hrs PRN
- Max: 8 tabs/day
Note:
- Dissolve tabs in 4 oz of water; do not chew or swallow the tablet whole
Pediatric Dosing
Common cold and other upper respiratory allergies
- Children <12 yrs: Use not recommended
- Children >12 yrs: 2 tabs dissolved in 4 oz of water PO q4 hrs PRN; max: 8 tabs/day
[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, difficulty breathing, and shock
- 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
- 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 - Discontinue therapy if sore throat becomes severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting; further evaluate the patient and provide appropriate therapy
- Therapy may cause marked drowsiness. Exercise caution when driving a motor vehicle or operating machinery
- Dizziness, drowsiness, or blurred vision may occur with this drug; concomitant use of other sedatives and tranquilizers and alcohol abuse may worsen these effects. Hence, avoid use of these drugs and advise patients to avoid alcohol during therapy
- Discontinue therapy and consult a clinician if new symptoms occur, redness or swelling is noted, pain/cough/nasal congestion gets worse or lasts more than 7 days, fever gets worse or lasts >3 days; nervousness, dizziness or sleeplessness occurs, or if cough comes back or occurs with rash or headache that lasts; further evaluate the patients as these could be signs of a serious condition
- Antihistamine produces paradoxical excitation in young children. Use of antihistamines is contraindicated in children <2 yrs
- Avoid use of this combination therapy to sedate children
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Peptic ulcer disease
- COPD
- History of GI bleed
- GI obstruction
- Increased intracranial pressure
- Intracranial lesion
- Diabetes mellitus
- GERD
- Gout
- Chronic alcohol abuse
- Coagulation disorder
- CHF
- Arrhythmias
- Asthma
- Increased IOP
- Angle-closure glaucoma
- Lower respiratory tract symptoms
- PKU (phenylalanine-containing forms)
- Hypertension
- Cardiovascular disease
- Bladder neck obstruction
- Hyperthyroidism
- Prostatic hypertrophy
- Geriatric patients
- Surgery or trauma
- Sodium-restricted diet
- Thrombocytopenia
- CNS depressant use
- Poor CYP2D6 metabolizer
- High environmental temperature
Supplemental Patient Information
- Advise patients to avoid driving a motor vehicle or operating machinery, as drowsiness may occur with this product
- Advise patients to consult their physician if symptoms do not improve in 7 days, if new symptoms occur, or if fever gets worse or lasts more than 3 days
- Instruct patients to avoid alcoholic beverages during therapy
- 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
Pregnancy Category:D aspirin; B chlorpheniramine; 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. Small, occasional doses of chlorpheniramine would not be expected to cause any adverse effects in breastfed infants. Larger doses or more prolonged use may cause adverse effects in the infant or interfere with lactation, particularly in combination with a sympathomimetic agent or when lactation is not well established. However, the nonsedating antihistamines are preferred alternatives. 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 7 December 2011).
