Ibuprofen and Pseudoephedrine hydrochloride IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE OHM LABORATORIES INC. FDA Approved Uses temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains
FunFoxMeds box
Substance Ibuprofen
Route
ORAL
Applications
ANDA074567

Drug Facts

Composition & Profile

Active Ingredients
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
Inactive Ingredients
Inactive ingredients 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
Strengths
200 mg 30 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Associated With The Common Cold Or Flu Headache Fever Sinus Pressure Nasal Congestion Minor Body Aches And Pains
Pill Appearance
Shape: oval Color: brown Imprint: 423

Identifiers & Packaging

Container Type BOX
UNII
WK2XYI10QM 6V9V2RYJ8N
Packaging

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton † Compare To the active ingredients of Advil ® Cold & Sinus NDC 51660-423-21 See New Warnings Information ohm ® Non-Drowsy Cold & Sinus Ibuprofen and Pseudoephedrine HCl Tablets, USP Ibuprofen, USP 200 mg – Pain Reliever/Fever Reducer (NSAID)* Pseudoephedrine HCl, USP 30 mg – Nasal Decongestant *nonsteroidal anti-inflammatory drug Relieves Sinus Pressure, Nasal Congestion and Fever 20 Coated Caplets** (**oval-shaped tablets) ibu-pseudo-20ct

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton † Compare To the active ingredients of Advil ® Cold & Sinus NDC 51660-423-21 See New Warnings Information ohm ® Non-Drowsy Cold & Sinus Ibuprofen and Pseudoephedrine HCl Tablets, USP Ibuprofen, USP 200 mg – Pain Reliever/Fever Reducer (NSAID)* Pseudoephedrine HCl, USP 30 mg – Nasal Decongestant *nonsteroidal anti-inflammatory drug Relieves Sinus Pressure, Nasal Congestion and Fever 20 Coated Caplets** (**oval-shaped tablets) ibu-pseudo-20ct

Overview

Uses temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains

Indications & Usage

Uses temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains

Dosage & Administration

Directions do not take more than directed the smallest effective dose should be used adults and children 12 years of age and over: take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used. do not use more than 6 caplets in any 24-hour period unless directed by a doctor children under 12 years of age: do not use

Warnings & Precautions
Warnings Allergy alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters 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: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning 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. 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) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition 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 When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling fever gets worse or lasts more than 3 days nasal congestion lasts for more than 7 days symptoms continue or get worse redness or swelling is present in the painful area you get nervous, dizzy, or sleepless any new symptoms appear If pregnant or breast-feeding, 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 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)
Purpose

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

Do Not Use

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) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

When Using

When using this product take with food or milk if stomach upset occurs

Stop Use & Ask a Doctor

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling fever gets worse or lasts more than 3 days nasal congestion lasts for more than 7 days symptoms continue or get worse redness or swelling is present in the painful area you get nervous, dizzy, or sleepless any new symptoms appear

Keep Out of Reach of Children

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)

Storage & Handling

Other information store at 20 - 25° C (68 - 77° F). Avoid excessive heat above 40° C (104° F). read all warnings and directions before use. Keep carton.

Questions

Questions? call 1-800-406-7984


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