Label: IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE tablet, sugar coated
- NDC Code(s): 51660-423-21, 51660-423-41
- Packager: Ohm Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 13, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Allergy alert
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
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- skin reddening
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- rash
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- 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:
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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- have 3 or more alcoholic drinks every day while using this product
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- 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
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- in children under 12 years of age
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- if you have ever had an allergic reaction to any other pain reliever/fever reducer
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- right before or after heart surgery
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- 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
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- stomach bleeding warning applies to you
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- you have problems or serious side effects from taking pain relievers or fever reducers
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- you have a history of stomach problems, such as heartburn
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- 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
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- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
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- under a doctor's care for any serious condition
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- taking any other product that contains pseudoephedrine or any other nasal decongestant
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- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
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- taking any other drug
Stop use and ask a doctor if
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- you have symptoms of heart problems or stroke:
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- chest pain
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- trouble breathing
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- weakness in one part or side of body
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- slurred speech
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- leg swelling
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- fever gets worse or lasts more than 3 days
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- nasal congestion lasts for more than 7 days
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- symptoms continue or get worse
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- redness or swelling is present in the painful area
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- you get nervous, dizzy, or sleepless
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- any new symptoms appear
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Directions
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- do not take more than directed
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- the smallest effective dose should be used
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- adults and children 12 years of age and over:
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- take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.
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- do not use more than 6 caplets in any 24-hour period unless directed by a doctor
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- children under 12 years of age: do not use
- Other information
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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
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton
†Compare To
the active ingredients of
Advil® Cold & SinusNDC 51660-423-21
See New Warnings Information
ohm®
Non-Drowsy
Cold & Sinus
Ibuprofen and Pseudoephedrine
HCl Tablets, USPIbuprofen, 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) -
INGREDIENTS AND APPEARANCE
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ibuprofen and pseudoephedrine hydrochloride tablet, sugar coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-423 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) CALCIUM CARBONATE (UNII: H0G9379FGK) CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) KAOLIN (UNII: 24H4NWX5CO) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) POWDERED CELLULOSE (UNII: SMD1X3XO9M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WHITE WAX (UNII: 7G1J5DA97F) GUAR GUM (UNII: E89I1637KE) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) Product Characteristics Color brown Score no score Shape OVAL (caplets) Size 14mm Flavor Imprint Code 423 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51660-423-21 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 10/13/2001 2 NDC:51660-423-41 40 in 1 BLISTER PACK; Type 0: Not a Combination Product 10/13/2001 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074567 10/13/2001 Labeler - Ohm Laboratories Inc. (184769029) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 MANUFACTURE(51660-423)
