Multi-Symptom Cold Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Multi-Symptom Cold Relief

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

CVS 44-591


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • nasal congestion
    • cough
    • sore throat
    • sinus congestion and pressure
    • sneezing and runny rose
  • helps clear nasal passages
  • relieves cough to help you sleep
  • temporarily reduces fever

Warnings

  • more than 12 gelcaps 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
Sore throat warning:

Sore Throat Warning:

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
  • persistent or chronic cough such as occurs with smoking, asthma, 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
  • taking sedatives or tranquilizers

When using this product

  • do not exceed recommended dosage
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery

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
  • new symptoms occur
  • 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.

If pregnant or breast-feeding,

Keep out of reach of children.

Overdose warning:
  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 gelcaps every 4 hours
    • do not take more than 12 gelcaps 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
  • store at controlled room temperature 15º-30º C (59º-86ºF)
  • see end flap for expiration date and lot number
1-800-774-2678

Principal Display Panel


CVS® pharmacy

Compare to the active ingredients in Tylenol® Cold Multi-Symptom Nighttime Caplets*

SEE NEW WARNINGS INFORMATION

Multi-Symptom

COLD RELIEF

PAIN RELIEVER, FEVER REDUCER, NASAL DECONGESTANT, COUGH SUPPRESSANT, ANTIHISTHAMINE

NIGHTTIME TO LET YOU SLEEP

CONTAINS 4 MEDICINES

Headache/Fever Sore Throat - Acetaminophen

Nasal Congestion - Phenylephrine HCl

Coughing - Dextromethorphan HBr

Runny Nose - Chlorpheniramine

RAPID RELEASE

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2001 CVS/pharmacy

www.cvs.com   1-200-shop-CVS

50844   ORG081059103

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

Multi-Symptom Cold Relief

Multi-Symptom Cold Relief

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Chlorpheniramine Maleate CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-591
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
CROSPOVIDONE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
hydroxypropyl cellulose
HYPROMELLOSES
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol
povidone
propylene glycol
SILICON DIOXIDE
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BLUE (gray band) 19 mm 44;591 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:59779-591-03 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2008-03-29


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