Non Drowsy Cold and Cough PE
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
CVS 44-546
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
Acetaminophen 325 mg
Dextromathorphan HBr 10 mg
Guaifenesin 100 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
- temporarily relieves these symptoms due to the common cold:
- nasal congestion
- headache
- minor aches and pains
- cough
- sore throat
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily reduces fever
Liver warning: This product contains acetaminophen. Sever 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 accompained or followed by fever, headache, rash, nausea, or vomiting, 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 shopping the MAOI, ask a doctor or pharmacist before taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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
When using this product
- do not exceed recommended dosage
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- 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.
- do not use more than directed (see overdose warning)
-
adults and children 12 years and over
- take 2 caplets every 4 hours
- do not take more than 12 caplets in 24 hours
- children under 12 years: do not uses 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-30ºC (59º-86ºF)
- see end flap for expiration date or lot number
corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maletodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gle, sodium starch glycolate, stearic acid, talc, titanium dioxide
1-800-426-9391
Principal Display Panel
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
CVS®
pharmacy
NDC 59779-546-03
Compare to the active ingredients in Sudafed PE® Cold & Cough*
NON-DROWSY
COUGH & COLD PE
MULTI-SYMPTOM
ACETAMINOPHEN, DEXTROMATHORPHAN HBr
GUAIFENESIN, PHENYLEPHRINE HCl
PAIN RELIEVER/FEVER REDUCER, EXPECTORANT
COUGH SUPPRESSANT, NASAL DECONGESTANT
•Nasal & sinus congestion
•Chest congestion
•Fever & body aches
•Cough & sore throat
Does not contain Pseudoephedrine
* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed ® PE Cold & Cough.
50844 REV0510B54603
Distributed by: CVS Pharmacy, Inc.
One CVS Ddrive, Woonsocket, RI 02895
© 2010 CVS/pharmacy
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Non Drowsy Cold and Cough PEAcetaminophen, Dextromathorphan HBr, Gauifenesin, Phenylephrine HCl CAPSULE, COATED
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