IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE- ibuprofen and pseudoephedrine hydrochloride tablet, sugar coated 
Chain Drug Consortium, LLC.

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Drug Facts

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

Premier Value®

NDC68016-423-21

*Compare to the active ingredients of Advil®Cold & Sinus

Non-Drowsy

Ibuprofen and Pseudoephedrine HCl Tablets, USP

Cold & Sinus Formula

Ibuprofen, USP 200 mg - Pain Reliever/Fever Reducer (NSAID)*

*nonsteroidal anti-inflammatory drug

Pseudoephedrine HCl, USP 30 mg - Nasal Decongestant

Relieves Sinus Pressure, Nasal Congestion and Fever

20 COATED CAPLETS

Oval-Shaped Tablets

DISTRIBUTED BY CHAIN DRUG CONSORTIUM

5097029/R0712

This is the 20 count blister carton label for Ibuprofen & Pseudoephedrine HCl  tablets, USP.
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 
ibuprofen and pseudoephedrine hydrochloride tablet, sugar coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-423
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 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 (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)  
TRISTEARIN (UNII: P6OCJ2551R)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
KAOLIN (UNII: 24H4NWX5CO)  
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)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
POVIDONES (UNII: FZ989GH94E)  
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:68016-423-21 20 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074567 10/13/2001
Labeler - Chain Drug Consortium, LLC. (101668460)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 184769029 MANUFACTURE(68016-423)

Revised: 10/2015
Document Id: 6ef1207c-c841-4777-a950-7ca37e1ec04f
Set id: f604ba33-dea5-44e1-a27c-a7e6766f0fa5
Version: 3
Effective Time: 20151006
 
Chain Drug Consortium, LLC.