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Drug Facts
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Ibuprofen And Pseudoephedrine Hydrochloride (NDC 0363-0423). 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 other, otc - purpose, uses, allergy alert, stomach bleeding warning, heart attack and stroke warning, do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
| Active ingredients (in each caplet) | Purposes |
|---|---|
| Ibuprofen, USP 200 mg (NSAID) nonsteroidal anti-inflammatory drug | Pain reliever/fever reducer |
| Pseudoephedrine HCl, USP 30 mg | Nasal decongestant |
temporarily relieves these symptoms associated with the common cold or flu:
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.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
If pregnant or breast-feeding, 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.
Keep out of reach of children. 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
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Compare to Advil® Cold & Sinus
active ingredients††
SEE NEW WARNINGS INFORMATION
NDC 0363-0423-21
NON-DROWSY
Wal-Profen® D
COLD & SINUS
IBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP
IBUPROFEN, USP 200 mg - PAIN RELIEVER / FEVER REDUCER (NSAID)*
PSEUDOEPHEDRINE HCl, USP 30 mg / NASAL DECONGESTANT
20
COATED CAPLETS**
(**Oval-Shaped Tablets)
*Nonsteroidal Anti-Inflammatory Drug
ACTUAL
SIZE
* Please review the disclaimer below.