Ibuprofen and Pseudoephedrine Hydrochloride: Package Insert and Label Information

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE- ibuprofen and pseudoephedrine hydrochloride tablet, sugar coated
Chain Drug Marketing Association Inc.

ACTIVE INGREDIENTS (IN EACH CAPLET)

Ibuprofen, USP 200 mg (NSAID)^*

Pseudoephedrine HCl, USP 30 mg

^* nonsteroidal anti-inflammatory drug

PURPOSES

Pain reliever/Fever reducer

Nasal decongestant

USES

Temporarily relieves these symptoms associated with the common cold or flu:

• fever
• sinus pressure
• nasal congestion
• headache
• minor body aches and pains

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 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
  • have bloody or black stools
  • vomit blood
  • 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.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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

• 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.
• 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 wax

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

QC QUALITY CHOICE _®

NDC 63868-453-20

^* Compare to the active ingredients in Advil ^® Cold & Sinus

NON-DROWSY

IBUPROFEN AND PSEUDOEPHEDRINE HCl TABLETS, USP

Cold & Sinus Formula

Ibuprofen, USP 200 mg — Pain Reliever/Fever Reducer (NSAID) ^٭

Pseudoephedrine HCl, USP 30 mg — Nasal Decongestant

FOR RELIEF OF:

• Sinus Pressure
• Nasal Congestion
• Fever

20 COATED CAPLETS ^† ( ^† Oval-Shaped Tablets)

^٭ nonsteroidal anti-inflammatory drug

^© DISTRIBUTED BY QUALITY CHOICE

5089124/R0811

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen and pseudoephedrine hydrochloride tablet, sugar coated

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-453 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg

Inactive Ingredients Ingredient Name Strength ACACIA CALCIUM CARBONATE CARNAUBA WAX STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GUAR GUM TRISTEARIN HYDROXYPROPYL CELLULOSE FERROSOFERRIC OXIDE KAOLIN POLYETHYLENE GLYCOLS POWDERED CELLULOSE POVIDONE STARCH, PREGELATINIZED CORN PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM BENZOATE SUCROSE TALC TITANIUM DIOXIDE WHITE WAX

Product Characteristics Color brown Score no score Shape OVAL (Caplets) Size 14mm Flavor Imprint Code 423 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63868-453-20 20 TABLET, SUGAR COATED (TABLET) in 1 BLISTER PACK None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074567 10/13/2001

Labeler — Chain Drug Marketing Association Inc. (011920774)

Registrant — Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Operations
Ohm Laboratories Inc.		184769029	manufacture (63868-453)

Revised: 09/2012 Chain Drug Marketing Association Inc.