Ibuprofen and Pseudoephedrine Hydrochloride: Package Insert and Label Information

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

Drug Facts

Active ingredients (in each caplet)	Purposes
* nonsteroidal anti-inflammatory drug
Ibuprofen, USP 200 mg (NSAID)*	Pain reliever/fever reducer
Pseudoephedrine HCl, USP 30 mg	Nasal decongestant

Uses

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

• headache
• fever
• sinus pressure
• nasal congestion
• 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

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 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.

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

Distributed By McKesson One Post Street, San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL — 200 mg/30 mg Caplet Blister Pack Carton

sunmark^®

COMPARE TO ADVIL^® COLD & SINUS
ACTIVE INGREDIENTS^†
NDC 49348-097-47

See New Warnings Information

cold & sinus relief

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

Non-Drowsy

20 Coated Caplets ** (**oval-shaped tablets)

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

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-097 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 (15 MPA.S AT 5%) FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GUAR GUM GLYCERYL TRISTEARATE HYDROXYPROPYL CELLULOSE (1200000 MW) FERROSOFERRIC OXIDE KAOLIN POLYETHYLENE GLYCOL, UNSPECIFIED POWDERED CELLULOSE POVIDONE, UNSPECIFIED 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:49348-097-47 20 TABLET, SUGAR COATED 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 — Sunmark (177667227)

Registrant — Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Operations
Ohm Laboratories Inc.		184769029	manufacture (49348-097)

Revised: 05/2018 Sunmark