Active Ingredients (In Each Caplet)
Ibuprofen, USP 200 mg (NSAID)*
Pseudoephedrine HCl, USP 30 mg
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets Inc for the product Ibuprofen And Pseudoephedrine Hydrochloride (NDC 56062-423). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purposes, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ibuprofen, USP 200 mg (NSAID)*
Pseudoephedrine HCl, USP 30 mg
*nonsteroidal anti-inflammatory drug
Pain reliever/Fever reducer
Nasal decongestant
Temporarily relieves these symptoms associated with the common cold or flu:
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Acacia, calcium carbonate, carnauba wax, confectioner’s sugar, corn starch, croscarmellose sodium, crospovidone, FD&C Blue no. 2 Aluminum Lake, FD&C Red no. 40 Aluminum Lake, FD&C Yellow no. 6 Aluminum Lake, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, iron oxide black, kaolin, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, propylene glycol, shellac, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax
Publix
NON-DROWSY
ibuprofen
cold & sinus
IBUPROFEN AND PSEUDOEPHEDRINE HCl TABLETS, USP
IBUPROFEN, USP 200 mg - PAIN RELIEVER/FEVER REDUCER (NSAID)*
PSEUDOEPHEDRINE HCl, USP 30 mg - NASAL DECONGESTANT
Relieves:
20 COATED CAPLETS**
**Oval-Shaped tablets
*nonsteroidal anti-inflammatory drug
***Compare to Active Ingredients in Advil®Cold & Sinus Caplets
DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.
5098347/0812
* Please review the disclaimer below.