Sinus Pressure description, usages, side effects, indications, overdosage, supplying and lots more!

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Sinus Pressure

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

CVS 44-502


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Nasal decongestant 

Sinus Pressure Uses

  • temporarily relieves headache, minor aches and pains
  • temporarily relieves nasal congestion 

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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 an MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if

taking the blood thinning drug warfarin. 

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not use more than directed (see overdose warning)
  • adults and children 12 ears and over
  • take 2 caplets every 4 hours
  • do not take more than 12 caplets in 24 hours
  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage. 

Sinus Pressure Other information

  • store at  25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

 corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silica gel, stearic acid

Principal Display Panel

CVS
pharmacy®

Compare to the active ingredients in Sudafed PE® Pressure + Pain*

MAXIMUM STRENGTH
SINUS PRESSURE
ACETAMINOPHEN,
PHENYLEPHRINE HYDROCHLORIDE
PAIN RELIEVER/FEVER REDUCER, NASAL DECONGESTANT
NON-DROWSY

Does not contain Pseudoephedrine

Sinus Pain & Headache
• Sinus Pressure
• Nasal & Sinus Congestion

24 TABLETS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Sinus Headache.
50844    REV0412B32652

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2013 CVS/pharmacy
www.cvs.com    1-800-shop-CVS

V-19849

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Sinus Pressure
CVS 44-502

Sinus Pressure

Acetaminophen and Phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-502
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
POVIDONES
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
ORANGE 17 mm 44;502 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 36 in 1 BLISTER PACK
3 NDC:59779-502-07 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-06-23


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Be sure to consult your doctor before taking any medication!
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