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

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Severe Sinus Congestion

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

CVS 44-574


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

 Acetaminophen 325 mg

Guaifenesin 200 mg

Pseudoephedrine HCl 30 mg

Pain reliever

Expectorant

Nasal decongestant 

  • temporarily relieves:
    • minor aches and pains
    • headache
    • nasal congestion
    • sinus congestion and pressure
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 

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

  • more than 8 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminphen
  • 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 if 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
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus) 

Ask a doctor or pharmacist before use if you are

  • 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, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts
  • 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 right away.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 4 to 6 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 8 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

Severe Sinus Congestion Other information

  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

crospovidone, D7C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelantinized corn starch, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

1-800-426-9391 

Principal Display Panel

CVS® pharmacy

Compare to the active ingredients in Tylenol® Sinus Severe Congestion Daytime*

See New Warnings Information

SEVERE SINUS CONGESTION

DAYTIME NON-DROWSY

PAIN RELIEVER, NASAL CONGESTANT, EXPECTORANT

CONTAINS 3 MEDICINES

• Headache - Acetaminophen

• Chest congestion - Guaifenesin

• Sinus pressure - Pseudoephedrine HCl

• Nasal & sinus congestion 

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

50844    REV0510B57408

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2010 CVS/pharmacy

Severe Sinus Congestion

Severe Sinus Congestion

Acetaminophen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-574
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Guaifenesin GUAIFENESIN 200 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 30 mg

Inactive Ingredients

Ingredient Name Strength
CROSPOVIDONE
D&C YELLOW NO. 10
MAGNESIUM STEARATE
maltodextrin
cellulose, microcrystalline
polyethylene glycol
POLYVINYL ALCOHOL
povidone
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
talc

Product Characteristics

Color Size Imprint Code Shape
GREEN 19 mm L;574 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:59779-574-08 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2008-06-09


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