FDA records indicate that there are no current recalls for this drug.
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Complete Allery And Sinus 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 you take:
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more than 12 caplets in 24 hours, which is the maximum daily amount
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with other drugs containing acetaminophen
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3 or more alcoholic drinks every day while using this product
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with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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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.
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liver disease
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diabetes
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heart disease
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high blood pressure
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thyroid disease
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trouble urinating due to an enlarged prostate gland
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a breathing problem such as emphysema or chronic bronchitis
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glaucoma
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taking the blood thinning drug warfarin
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taking sedatives or tranquilizers
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do not exceed recommended dosage
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excitability may occur, especially in children
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drowsiness may occur
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alcohol, sedatives, and tranquilizers may increase drowsiness
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avoid alcoholic drinks
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be careful when driving a motor vehicle or operating machinery
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nervousness, dizziness, or sleeplessness occur
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pain or nasal congestion gets worse or lasts more than 7 days
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new symptoms occur
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fever gets worse or lasts more than 3 days
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redness or swelling is present
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 or symptoms.
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with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
-
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.
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liver disease
-
diabetes
-
heart disease
-
high blood pressure
-
thyroid disease
-
trouble urinating due to an enlarged prostate gland
-
a breathing problem such as emphysema or chronic bronchitis
-
glaucoma
-
taking the blood thinning drug warfarin
-
taking sedatives or tranquilizers
-
nervousness, dizziness, or sleeplessness occur
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pain or nasal congestion gets worse or lasts more than 7 days
-
new symptoms occur
-
fever gets worse or lasts more than 3 days
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redness or swelling is present
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
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temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
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sinus congestion and pressure
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nasal congestion
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runny nose and sneezing
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headache
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minor aches and pains
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temporarily relieves these additional symptoms of hay fever:
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itching of the nose or throat
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itchy, watery eyes
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helps clear nasal passages
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helps decongest sinus openings and passages
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Complete Allery And Sinus Multi-symptom Manufacturers
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Great Lakes Wholesale, Marketing, & Sales, Inc.
Complete Allery And Sinus Multi-symptom | E.r. Squibb & Sons, L.l.c.
2.1 Recommended DosageThe recommended dosage of DAKLINZA is 60 mg, taken orally, once daily in combination with sofosbuvir for 12 weeks. DAKLINZA may be taken with or without food.
The optimal duration of DAKLINZA and sofosbuvir for patients with cirrhosis has not been established [see Clinical Studies (14)].
For specific dosage recommendations for sofosbuvir, refer to the respective prescribing information.
2.2 Dosage Modification Due to Drug InteractionsRefer to the drug interactions and contraindication sections for other drugs before coadministration with DAKLINZA.
Strong inhibitors of cytochrome P450 enzyme 3A (CYP3A): Reduce the dosage of DAKLINZA to 30 mg once daily when coadministered with strong CYP3A inhibitors using the 30 mg tablet [see Drug Interactions (7)].
Moderate CYP3A inducers: Increase the dosage of DAKLINZA to 90 mg once daily using an appropriate combination of tablets (three 30 mg tablets or one 60 mg and one 30 mg tablet) when coadministered with moderate CYP3A inducers [see Drug Interactions (7)].
Strong CYP3A inducers: DAKLINZA is contraindicated in combination with strong CYP3A inducers [see Contraindications (4)].
Dosage reduction of DAKLINZA for adverse reactions is not recommended.
2.3 Discontinuation of TherapyIf sofosbuvir is permanently discontinued in a patient receiving DAKLINZA with sofosbuvir, then DAKLINZA should also be discontinued.
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