TOPCARE CONGESTION RELIEF- ibuprofen, phenylephrine hcl tablet, film coated 
Topco Associates LLC

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Topco Associates LLC. Congestion Relief Drug Facts

Active ingredients (in each tablet)

Ibuprofen 200 mg (NSAID)*

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

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
reduces swelling of the nasal passages
temporarily restores freer breathing through the nose

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

in children under 12 years of age because this product contains too much medication for children under this 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 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 product that contains phenylephrine 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
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
pain gets worse or lasts more than 7 days
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
adults and children 12 years of age and over:
take 1 tablet every 4 hours while symptoms persist.
do not use more than 6 tablets in any 24-hour period unless directed by a doctor
children under 12 years of age: do not use because this product contains too much medication for children under this age

Other information

store at 20-25°C (68-77°). Avoid excessive heat above 40°C (104°F).
read all warnings and directions before use. Keep carton.

Inactive Ingredients

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide

Questions?

1-888-423-0139

Principal Display Panel

1 PILL DOSAGE

Congestion Relief

IBUPROFEN 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

PHENYLEPHRINE HYDROCHLORIDE 10 mg NASAL DECONGESTANT, TABLETS

NON-DROWSY relief of Sinus Pressure, Nasal Swelling & Congestion, and Headache

CONTAINS: Ibuprofen & Phenylephrine

COMPARE TO ADVIL® CONGESTION RELIEF active ingredients

actual size

1 PILL DOSAGE

20 COATED TABLETS

Topcare Congestion Relief Image 1.jpg
Topcare Congestion Relief Image 2
TOPCARE CONGESTION RELIEF 
ibuprofen, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-158
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (brownish-orange) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code L158
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-158-6020 in 1 CARTON01/06/201506/27/2018
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20320001/06/201506/27/2018
Labeler - Topco Associates LLC (006935977)

Revised: 3/2018
 
Topco Associates LLC