Severe Cold Relief PE description, usages, side effects, indications, overdosage, supplying and lots more!

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Severe Cold Relief PE

WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
L.N.K. International, Inc.




FULL PRESCRIBING INFORMATION

(in each caplet)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

  • temporarily relieves these symptoms of the common cold:
  • runny nose
  • sneezing
  • headache
  • minor aches and pains
  • nasal congestion
  • cough
  • 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
  • diabetes
  • 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

1-800-426-9391

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 in

Sudafed PE® Severe Cold*

See New Warnings Information

SEVERE

COLD RELIEF PE

MULTI-SYMPTOM

ACETAMINOPHEN,

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

50844           REV1209B52608

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2010 CVS/pharmacy

www.cvs.com

1-800-shop-CVS

Severe Cold Relief PE

Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-526
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 12.5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol
POLYVINYL ALCOHOL
povidone
SILICON DIOXIDE
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 17 mm 44;526 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 24 in 1 BLISTER PACK
3 NDC:59779-526-08 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-06-21


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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