Head Congestion Cold Relief by WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Dosage form: tablet, film coated
Ingredients: Acetaminophen 325mg, Dextromethorphan Hydrobromide 10mg, Phenylephrine Hydrochloride 5mg
Labeler: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
NDC Code: 59779-470
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.
(in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
- temporarily relieves theses common cold symptoms:
- minor aches and pains
- nasal congestion
- sore throat
- sinus congestion and pressure
- helps clear nasal passages
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 vommiting, 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. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- 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)
- taking the blood thinning drug warfarin
- do not exceed recommended dosage
- 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, croscarmellose sodium, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, sucralose, talc, titanium dioxide
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
Compare to the active
ingredients of Tylenol® Cold
Head Congestion Daytime*
See New Warnings
PAIN RELIEVER, NASAL DECONGESTANT,
CONTAINS 3 MEDICINES
Headache Pain -
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
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2010 CVS/pharmacy
|HEAD CONGESTION COLD RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated
|Labeler - WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)|
|Registrant - L.N.K. International, Inc. (832867837)|
|L.N.K. International, Inc||832867894||MANUFACTURE|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.