FDA records indicate that there are no current recalls for this drug.
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Severe Cold Pe Multi-symptom Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
- 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
- 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)
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- 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
- 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.
ask a health professional before use.
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.
- 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
- 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)
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Severe Cold Pe Multi-symptom Manufacturers
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Supervalu Inc.
Severe Cold Pe Multi-symptom | Supervalu Inc.
do not use more than directed (see overdose warning) adults and children 12 years and overtake 2 caplets every 4 hours
do not take more than 12 caplets in 24 hours
children 6 to under 12 years of agetake 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
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