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

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Sinus Congestion and Pain

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

CVS 44-455C


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg


Purpose

Pain reliever
Antihistamine
Nasal decongestant

Sinus Congestion and Pain Uses

  • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • sinus congestion and pressure

  • nasal congestion

  • runny nose and sneezing

  • headache

  • minor aches and pains

  • temporarily relieves these additional symptoms of hay fever:

  • itching of the nose or throat

  • itchy, watery eyes

  • helps clear nasal passages

  • helps decongest sinus openings and passages

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 12 caplets in 24 hours, which is the maximum daily amount

  • 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 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 you have

  • liver disease

  • diabetes

  • heart disease

  • high blood pressure

  • thyroid disease

  • trouble urinating due to an enlarged prostate gland

  • a breathing problem such as emphysema or chronic bronchitis

  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

  • taking sedatives or tranquilizers

When using this product

  • do not exceed recommended dosage

  • excitability may occur, especially in children

  • drowsiness may occur

  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • avoid alcoholic drinks

  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur

  • pain or nasal congestion gets worse or lasts more than 7 days

  • new symptoms occur

  • fever gets worse or lasts more than 3 days

  • redness or swelling is present

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 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 take more than directed (see overdose warning)

  • adults and children 12 years and over

  • take 2 caplets every 4 hours

  • swallow whole - do not crush, chew, or dissolve

  • 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 Congestion and Pain Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

Call 1-800-426-9391

Principal Display Panel

50% MORE FREE
36
for the price of 24

CVS®
pharmacy

Compare to the active ingredients in Tylenol® Sinus Congestion & Pain Nighttime*

SINUS
CONGESTION & PAIN
NIGHTTIME
PAIN RELIEVER, ANTIHISTAMINE, NASAL DECONGESTANT
Contains 3 medicines
• Runny nose/sneezing - Chlorpheniramine maleate
• Headache - Acetaminophen
• Nasal Congestion
• Sinus pain/pressure - Phenylephrine HCl

Pseudoephedrine Free

36 Cool Caplets
with Cool Blast Flavor

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Tylenol® Sinus Congestion & Pain NIghttime.
50844    ORG081045507

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2011 CVS/pharmacy
www.cvs.com    1-800-shop-CVS

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

Sinus Congestion and Pain
CVS 44-455C

Sinus Congestion and Pain

Acetaminophen, Chlorpheniramine Maleate and Phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-455
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
CROSPOVIDONE
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Sucralose
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 16 mm 44;455 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:59779-455-07 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2006-05-30


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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