Severe Cold PE Multi-Symptom Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL POVIDONES STEARIC ACID TALC TITANIUM DIOXIDE 44;526
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel equa line® compare to the active ingredients Sudafed PE® Severe Cold* NDC 41163-526-08 severe cold PE multi-symptom severe acetaminophen ,diphenhydramine HCl, phenylephrine HCl pain reliever/fever reducer, antihistamine/cough suppressant, nasal decongestant • fever & body aches • cough & sore throat • nasal & sinus congestion pseudoephedrine free 24 coated caplets DOES NOT CONTAIN GLUTEN *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Severe Cold. 50844 REV0313D52608 DISTRIBUTED BY SUPERVALU INC. EDEN PRARIE, MN 55344 USA Contact us at 1-877-932-7948, or www.supervalu-ourownbrands.com TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Equaline 44-526 Equaline 44-526
- Principal Display Panel equa line® compare to the active ingredients Sudafed PE® Severe Cold* NDC 41163-526-08 severe cold PE multi-symptom severe acetaminophen ,diphenhydramine HCl, phenylephrine HCl pain reliever/fever reducer, antihistamine/cough suppressant, nasal decongestant • fever & body aches • cough & sore throat • nasal & sinus congestion pseudoephedrine free 24 coated caplets DOES NOT CONTAIN GLUTEN *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Severe Cold. 50844 REV0313D52608 DISTRIBUTED BY SUPERVALU INC. EDEN PRARIE, MN 55344 USA Contact us at 1-877-932-7948, or www.supervalu-ourownbrands.com TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Equaline 44-526 Equaline 44-526
Overview
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
Indications & Usage
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
Dosage & Administration
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
Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adults take more than 12 caplets in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks ever day while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, naussea, or vomitting, consult 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 the MAOI drug. If you do not know if your prescription drug contains 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) 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) 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 Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms.
Purpose
Purpose Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant
Do Not Use
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 the MAOI drug. If you do not know if your prescription drug contains 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
When Using
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 Questions or comments? 1-877-932-7948
Stop Use & Ask a Doctor
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) 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.
Keep Out of Reach of Children
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 Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms.
Storage & Handling
Other information see end flap for expiration date and lot number store at controlled room temperature 15º-30ºC (59º-86ºF)
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.