Ibuprofen/Pseudoephedrine

DEA Class; OTC

Common Brand Names; Advil Cold and Sinus

Cough/Cold, Other Combos; 

Analgesic/Decongestant Combos

OTC oral NSAID/decongestant combination for sinus congestion, headache, mild pain, fever; NSAIDs may increase risk of serious GI and CV events; use lowest effective dose for shortest possible duration; per FDA issued a Public Health Advisory do NOT use in those < 2 years.

For the temporary relief of nasal congestion, sinus congestion, fever, sore throat, body aches (mild pain), and/or headache pain caused by allergies (hay fever), the common cold or flu, and sinusitis.

Hypersensitivity

Immediately before or after heart surgery

History of induced asthma or urticaria with NSAIDs

Longer than 3 days (fever) or 7 days (nasal congestion)

Children <12 years

Use with or within 2 weeks of discontinuing MAO inhibitors

GI upset

Insomnia

Arrhythmia

Palpitations

Convulsion

Dizziness

Drowsiness

Excitability

Headache

Tremor

Weakness

NauseaVomiting

Hemolytic anemia

Aplastic anemia

Arrhythmia

Bronchospasm

Caution with hypertension, heart disease, hepatic or renal impairment, asthma, thyroid disease, diabetes, BPH, peptic ulcer disease

If pregnant or breastfeeding, ask a health professional before use; it is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor; it may cause problems in the unborn child or complications during delivery

Ibuprofen

There are no adequate and well-controlled studies in pregnant women; data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive

Pseudoephedrine

Avoid, during first trimester; may be associated with possible risk of gastroschisis, small intestinal atresia, and hemifacial microsomia due to pseudoephedrine’s vasoconstrictive effects; magnitude of risk unknown

Fetal tachycardia reported following maternal use of extended-release formulation for multiple days

Lactation

Ibuprofen

• No lactation studies have been conducted; however, limited published literature reports that, following oral administration, ibuprofen is present in human milk at relative infant doses of 0.06-0.6% of the maternal weight-adjusted daily dose; no information is available on effects of ibuprofen on milk production or on a breastfed infant

Pseudoephedrine

• Excreted in breast milk; irritability reported in nursing infants (limited data); milk production may be decreased in some women

6 tablets/day PO.

6 tablets/day PO.

6 tablets/day PO.

6—11 years: 40 mL/day PO oral suspension.
2—5 years: 20 mL/day PO oral suspension.
< 2 years (< 24 lbs): Safety and efficacy have not been established.

ibuprofen/pseudoephedrine

Taplet

• 200mg/30mg

Liquid gel capsule

• 200mg/30mg