SEVERE COLD RELIEF PE- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated

Severe Cold Relief PE by

Drug Labeling and Warnings

Severe Cold Relief PE by is a Otc medication manufactured, distributed, or labeled by WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, L.N.K. International, Inc., L.N.K. International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

(in each caplet)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Uses

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

Warnings

Liver warning:

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

Sore throat warning:

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.

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.
• 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

Ask a doctor before use if the user has

• 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

Ask a doctor or pharmacist before use if the user is

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

• 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

Stop use and ask a doctor if

• 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.

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 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.

Directions

• 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

Other information

• see end flap for expiration date and lot number
• store at controlled room temperature 15°-30°C (59°-86°F)

Inactive ingredients

corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, talc, titanium dioxide

Questions or comments?

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 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

INGREDIENTS AND APPEARANCE

SEVERE COLD RELIEF PE  
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-526
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	12.5 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg

Inactive Ingredients
Ingredient Name	Strength
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)
Talc (UNII: 7SEV7J4R1U)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	44;526
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-526-02	1 in 1 CARTON
1		12 in 1 BLISTER PACK
2	NDC: 59779-526-08	1 in 1 CARTON
2		24 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	06/21/2005

Labeler - WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)

Registrant - L.N.K. International, Inc. (832867837)

Establishment
Name	Address	ID/FEI	Business Operations
L.N.K. International, Inc		832867894	MANUFACTURE