ADVIL COLD & SINUS TAB

Indications

Approved Uses

Temporary relief of symptoms associated with the common cold, flu, or sinusitis, including nasal congestion, sinus pressure, headache, fever, and minor body aches and pains.

Dosage & Administration

Dosing by Condition

Adults and children ≥12 years: 1 tablet every 4-6 hours as needed; if needed, 2 tablets may be used per dose; do not exceed 6 tablets in 24 hours; do not use >7 days unless directed by a clinician.

Initial Dose

1-2 tablets (Ibuprofen 200-400mg + Pseudoephedrine HCl 30-60mg)

Maintenance Dose

1-2 tablets every 4 to 6 hours as needed.

Maximum Dose

Maximum 6 tablets in 24 hours (ibuprofen 1200 mg + pseudoephedrine HCl 180 mg).

Children's Dosage

Not for use in children under 12 years of age.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; use caution in older adults and in renal impairment; avoid in severe renal impairment; avoid in severe hepatic impairment; do not use longer than 7 days for OTC cold/sinus symptoms unless directed by a clinician.

How to Take

Swallow tablets/caplets whole with a full glass of water; do not crush or chew; may take with food or milk if stomach upset occurs.

Side Effects

Common Side Effects

Stop use if you get nervous, dizzy, or sleepless.

Safety & Warnings

Contraindications

Do not use: in children under 12 years of age; if you have ever had an allergic reaction to any other pain reliever/fever reducer; right before or after heart surgery; if you are now taking a prescription monoamine oxidase inhibitor (MAOI), or for 2 weeks after stopping the MAOI drug.

Warnings & Precautions

Warnings/precautions: increased risk of heart attack/stroke and serious stomach bleeding with NSAIDs; use caution/seek advice if history of ulcers/GI bleed, heart disease, hypertension, kidney or liver disease, asthma/NSAID allergy, diabetes, thyroid disease, glaucoma, enlarged prostate/urinary retention; avoid other NSAIDs/ibuprofen or other decongestants; do not use with MAOIs; limit duration (generally ≤7 days for symptoms; fever ≤3 days unless directed).

Age Restriction

Not for use in children under 12 years (≥12 years only).

Drug Interactions

Drug Interactions

Ask a doctor or pharmacist before use if you are taking any other product that contains pseudoephedrine or any other nasal decongestant; taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin; taking any other drug.

Interaction Severity

MAJOR: MAO inhibitors (contraindicated during and within 2 weeks).

Food Interaction

May take with food or milk to lessen stomach upset (not required for efficacy).

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not for use in children under 12 years of age.

Elderly

Stomach bleeding risk higher if age 60 or older.

Storage & Patient Advice

Storage Conditions

Store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).

Stopping the Medicine

Safe to stop anytime when symptoms resolve; no tapering required for short-term OTC use.

Patient Counseling

Swallow whole; may take with food/milk if GI upset. Do not exceed 6 tablets/24 h and avoid using >7 days unless advised. Avoid alcohol and other NSAID/ibuprofen-containing products. Do not use with/within 14 days of an MAOI. Use caution/seek advice if you have hypertension/heart disease, thyroid disease, diabetes, glaucoma, or difficulty urinating/BPH. Stop and seek care for chest pain, shortness of breath, severe headache, allergic reaction, black/tarry stools, or severe stomach pain; avoid in 3rd-trimester pregnancy.

Monitoring Requirements

No routine monitoring for short-term OTC use; consider monitoring blood pressure/heart rate in patients with hypertension or cardiovascular disease and watch for GI bleeding symptoms.

Pharmacology

Duration of Effect

4-6 hours

Product Information

Available Dosage Forms

Tablet, coated (caplet).

Composition per Dose

Each tablet: Ibuprofen 200mg + Pseudoephedrine Hydrochloride 30mg

Symptom Target

Multi-symptom

Sedating

No

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