Label: GOOD NEIGHBOR PHARMACY IBUPROFEN COLD AND SINUS- ibuprofen, pseudoephedrine hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68258-8902-2 - Packager: Dispensing Solutions, Inc.
- This is a repackaged label.
- Source NDC Code(s): 24385-465
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 5, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- Uses
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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
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 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
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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
- 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, FD&C red no. 40, FD&C yellow no. 6, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, kaolin, pharmaceutical ink, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax
- Questions or comments?
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Principal Display Panel
COMPARE TO ACTIVE INGREDIENTS IN ADVIL® COLD & SINUS
Non Drowsy
Ibuprofen Cold & Sinus
Ibuprofen 200 mg – Pain Reliever/Fever Reducer (NSAID)*
Pseudoephedrine HCl 30 mg – Nasal Decongestant
Tablets, USP
*nonsteroidal anti-inflammatory drug
Relieves Sinus Pressure, Nasal Congestion and Fever
See New Warnings Information
**OVAL-SHAPED TABLETS
NDC 68258-8902-02
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INGREDIENTS AND APPEARANCE
GOOD NEIGHBOR PHARMACY IBUPROFEN COLD AND SINUS
ibuprofen, pseudoephedrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68258-8902(NDC:24385-465) 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) SUCROSE (UNII: C151H8M554) 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) GUAR GUM (UNII: E89I1637KE) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) KAOLIN (UNII: 24H4NWX5CO) POWDERED CELLULOSE (UNII: SMD1X3XO9M) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BENZOATE (UNII: OJ245FE5EU) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WHITE WAX (UNII: 7G1J5DA97F) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) Product Characteristics Color BROWN Score no score Shape OVAL Size 15mm Flavor Imprint Code 083 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68258-8902-2 2 in 1 CARTON 1 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074567 10/15/2001 Labeler - Dispensing Solutions, Inc. (066070785) Registrant - PSS World Medical, Inc. (101822682) Establishment Name Address ID/FEI Business Operations Dispensing Solutions, Inc. 066070785 relabel(68258-8902) , repack(68258-8902)