Label: SEVERE COLD RELIEF PE- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-526-02, 59779-526-08 - Packager: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated August 26, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
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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
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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
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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
- When using this product
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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,
- Keep out of reach of children.
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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
- Inactive ingredients
- Questions or comments?
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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
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INGREDIENTS AND APPEARANCE
SEVERE COLD RELIEF PE
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coatedProduct 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