HEAD CONGESTION COLD RELIEF - acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated 
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

(in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Cough suppressant

Nasal decongestant

Uses

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

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

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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

Other information

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

Product Label
HEAD CONGESTION COLD RELIEF  
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-470
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
Starch, Corn (UNII: O8232NY3SJ)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
Magnesium Stearate (UNII: 70097M6I30)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Polyethylene Glycol (UNII: 3WJQ0SDW1A)  
Polyvinyl Alcohol (UNII: 532B59J990)  
Povidone (UNII: FZ989GH94E)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Sucralose (UNII: 96K6UQ3ZD4)  
Talc (UNII: 7SEV7J4R1U)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize17mm
FlavorMENTHOL (Cool Flavored) Imprint Code 44;470
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-470-011 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/11/2006
Labeler - WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)
Registrant - L.N.K. International, Inc. (832867837)
Establishment
NameAddressID/FEIBusiness Operations
L.N.K. International, Inc832867894MANUFACTURE

Revised: 8/2010
Document Id: bddddfc8-2fdf-7e68-7422-1c1656705a87
Set id: ebe9d74d-d382-1cdc-a5ea-94070cb5e6ac
Version: 1
Effective Time: 20100830
 
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED