Severe Cold Relief PE
Medically reviewed on August 28, 2017.
Dosage form: tablet, film coated
Ingredients: Acetaminophen 325mg, Diphenhydramine Hydrochloride 12.5mg, Phenylephrine Hydrochloride 5mg
Labeler: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
NDC Code: 59779-526
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
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
- temporarily relieves these symptoms of the common cold:
- runny nose
- minor aches and pains
- nasal congestion
- sore throat
- temporarily reduces fever
This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than 12 caplets in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours
- taking with other drugs containing acetaminophen
- adult has 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, condult 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.
- with any other product containing diphenhydramine, even one used on skin
- 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 an 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
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- a cough accompanied by too much phlegm (mucus)
- a persistant or chronic cough such as occurs with smoking, asthma, or emphysema
- a breathing problem such as emphysema or chronic bronchitis
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- do not exceed recommended dosage
- excitability may occur, especially in children
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- nervousness, dizziness, or sleeplessness occur
- pain, cough or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
- 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.
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 Centrer 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 6 to under 12 years of age||
take one caplet every 4 hours
do not take more than 5 caplets in 24 hours
|children under 6 years of age||do not use this product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage|
- see end flap for expiration date and lot number
- store at controlled room temperature 15°-30°C (59°-86°F)
corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, 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 in
Sudafed PE® Severe Cold*
See New Warnings Information
COLD RELIEF PE
DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl
PAIN RELIEVER/FEVER REDUCER, ANTIHISTAMINE
COUGH SUPPRESSANT, NASAL DECONGESTANT
● Nasal & Sinus Congestion
● Fever & Body Aches
● Cough & Sore Throat
Does not contain Pseudoephedrine
24 COATED CAPLETS
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED 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
|SEVERE COLD RELIEF PE
acetaminophen, diphenhydramine hcl, 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.