Head Congestion Cold Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Head Congestion Cold Relief

WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
L.N.K. International, Inc.




FULL PRESCRIBING INFORMATION

(in each caplet)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Pain reliever

Antihistamine

Cough suppressant

Nasal decongestant

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

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

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • 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, ask a doctor or pharmacist before taking this product.
  • liver disease
  • diabetes
  • heart disease
  • high blood pressure
  • glaucoma
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
  • 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
  • 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.

These could be signs of a serious condition.

ask a health professional before use.

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 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
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

corn starch, FD&C blue #1, FD&C blue #2, flavor, magnesium stearate, microcrystalline cellulose,polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

1-800-426-9391

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

CVS®

pharmacy

Compare to the active

 ingredients of Tylenol® Cold

Head Congestion Nighttime*

See New Warnings

Information

HEAD CONGESTION

COLD RELIEF

PAIN RELIEVER, NASAL DECONGESTANT,

COUGH SUPPRESSANT, ANTIHISTAMINE

NIGHTTIME

TO LET YOU SLEEP

CONTAINS 4 MEDICINES

Headache Pain -

- Acetaminophen

Sore Throat -

Nasal Congestion - Phenylephrine HCl

Coughing - Dextromethorphan HBr

Runny Nose - Chlorpheniramine Maleate

12  COOL ICE® CAPLETS

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

50844                 REV1009A47302

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2010 CVS/pharmacy

www.cvs.com

1-800-shop-CVS

Head Congestion Cold Relief

Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-473
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
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
FD&C BLUE NO. 1
FD&C BLUE NO. 2
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol
POLYVINYL ALCOHOL
povidone
SILICON DIOXIDE
STEARIC ACID
Sucralose
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BLUE 17 mm 44;473 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:59779-473-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-07-21


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