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  5. Label Information: Head Congestion Cold Relief

FDA Label for Head Congestion Cold Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. LIVER WARNING:
    5. SORE THROAT WARNING:
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. IF PREGNANT OR BREAST-FEEDING,
    12. KEEP OUT OF REACH OF CHILDREN.
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. PRODUCT PACKAGING

Head Congestion Cold Relief Product Label

The following document was submitted to the FDA by the labeler of this product Woonsocket Prescription Center, Incorporated. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



(in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Purpose



Pain reliever

Cough suppressant

Nasal decongestant


Uses



  • temporarily relieves theses common cold symptoms:
  • minor aches and pains
  • headache
  • nasal congestion
  • cough
  • sore throat
  • sinus congestion and pressure
  • helps clear nasal passages

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

Sore Throat Warning:



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


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



  • diabetes
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • heart disease
  • liver disease
  • 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
  • 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.


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

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


Questions Or Comments?



Call 1-800-426-9391


Product Packaging



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 Daytime*

See New Warnings

Information

HEAD CONGESTION

COLD RELIEF

PAIN RELIEVER, NASAL DECONGESTANT,

COUGH SUPPRESSANT

DAYTIME

NON-DROWSY

CONTAINS 3 MEDICINES

Headache Pain -

- Acetaminophen

Sore Throat -

Nasal Congestion - Phenylephrine HCl

Coughing - Dextromethorphan HBr

12 COOL ICE® CAPLETS

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

50844             REV1009A47002

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2010 CVS/pharmacy

www.cvs.com               1-800-shop-CVS


* Please review the disclaimer below.