FDA Label for Severe Cold Relief Pe
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- LIVER WARNING:
- SORE THROAT WARNING:
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF THE USER HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE USER IS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRODUCT PACKAGING
Severe Cold Relief Pe Product Label
The following document was submitted to the FDA by the labeler of this product Woonsocket Prescription Center, Incorporated. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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
1-800-shop-CVS
* Please review the disclaimer below.