Severe Cold PE Multi-Symptom
Equaline 44-526
FULL PRESCRIBING INFORMATION: CONTENTS*
- Active ingredients (in each caplet)
- Purpose
- Severe Cold PE Multi-Symptom Uses
- Warnings
- Directions
- Severe Cold PE Multi-Symptom Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
FULL PRESCRIBING INFORMATION
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
Severe Cold PE Multi-Symptom 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:
- 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.
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 |
Severe Cold PE Multi-Symptom Other information
- see end flap for expiration date and lot number
- store at controlled room temperature 15º-30ºC (59º-86ºF)
Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, talc, titanium dioxide
Questions or comments?
1-877-932-7948
Principal Display Panel
equaline®
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
Severe Cold PE Multi-SymptomAcetaminophen, Diphenhydramine HCl and Phenylephrine HCl TABLET, FILM COATED
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