Label: IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE- 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
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENTS (IN EACH CAPLET)
- sinus pressure
- nasal congestion
- minor body aches and pains
- facial swelling
- asthma (wheezing)
- skin reddening
- 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
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- 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.
- in children under 12 years of age
- right before or after heart surgery
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 or have trouble urinating due to an enlarged prostate gland
- 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 drug
- 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
When using this product
- take with food or milk if stomach upset occurs
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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
- symptoms continue or get worse
- any new symptoms appear
- you get nervous, dizzy, or sleepless
- fever gets worse or lasts more than 3 days
- nasal congestion lasts for more than 7 days
- redness or swelling is present in the painful area
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.
- 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
- OTHER INFORMATION
- store at 20 - 25º C (68 - 77º F). Avoid excessive heat above 40º C (104º F).
- read all warnings and directions before use. Keep carton.
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
- 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 waxClose
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ibuprofen and pseudoephedrine hydrochloride tablet, sugar coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-423 Route of Administration ORAL DEA Schedule 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 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 (UNII: 68401960MK) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) KAOLIN (UNII: 24H4NWX5CO) POVIDONE (UNII: FZ989GH94E) POWDERED CELLULOSE (UNII: SMD1X3XO9M) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) 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 GLYCOLS (UNII: 3WJQ0SDW1A) 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 2 NDC:51660-423-41 40 in 1 BLISTER PACK 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)