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← See all Ibuprofen and Pseudoephedrine Hydrochloride brands

Ibuprofen and Pseudoephedrine Hydrochloride

Dosage form: tablet, sugar coated
Ingredients: IBUPROFEN 200mg, PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: HEB
NDC Code: 37808-423

H-E-B® Cold & Sinus Relief

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

PRINCIPAL DISPLAY PANEL - 40 Caplet Blister Pack Carton

Compare to Advil® Cold & Sinus active ingredients

NDC 37808-423-40

H-E-B®

Cold & Sinus Relief

Ibuprofen, USP 200 mg / Pain Reliver/Fever Reducer (NSAID)*
Pseudoephedrine HCl, USP 30 mg / Nasal Decongestant

Cold & Sinus *nonsteroidal anti-inflammatory drug

Non-Drowsy

Relief of:

Fever • Sinus Pressure
Nasal Congestion

40 COATED CAPLETS**
(**oval-shaped tablets)

actual
size

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 
ibuprofen and pseudoephedrine hydrochloride tablet, sugar coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-423
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
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 
Product Characteristics
ColorbrownScoreno score
ShapeOVAL (Caplets) Size14mm
FlavorImprint Code423
Contains    
Packaging
#Item CodePackage Description
1NDC:37808-423-4040 TABLET, SUGAR COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07456704/17/2018
Labeler - HEB (007924756)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.184769029MANUFACTURE(37808-423)

 
HEB

← See all Ibuprofen and Pseudoephedrine Hydrochloride brands

Medically reviewed on Apr 17, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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