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Non-Drowsy Sinus Daytime by GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
NDC Code: 64092-845
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.
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Pain reliever
Nasal decongestant
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for the temporary relief of:
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headache
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sinus congestion and pressure
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minor aches and pains
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nasal congestion
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helps decongest sinus openings and passages
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promotes sinus drainage
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helps clear nasal passages
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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taking the blood thinning drug warfarin
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do not exceed recommended dosage
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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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fever gets worse or lasts more than 3 days
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redness or swelling is present
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new symptoms occur
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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do not take more than directed (see overdose warning)
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adults and children 12 years and over
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take 2 caplets every 4 hours
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swallow whole – do not crush, chew, or dissolve
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do not take more than 12 caplets in 24 hours
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children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
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store at controlled room temperature 15°-30°C (59°-86°F)
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see end flap for expiration date and lot number
corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
HEALTHCARE™
NDC 64092-845-24
SEE NEW WARNINGS INFORMATION
Non-Drowsy Sinus
Daytime CAPLETS
Acetaminophen 325 mg, Phenylephrine HCl 5 mg
Pain Reliever, Nasal Deongestant
Relieves,
• Headaches Pain
• Sinus Pressure
• Nasal Congestion
Pseudoephedrine FREE
*Compare to the active ingredients
in Tylenol® Sinus Congestion &
Pain Daytime Caplets
24 COOL CAPLETS
with Cool Blast Flavor
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844 REV0310B46608
Distributed by:
Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E.
Grand Rapids, MI 49512
1-800-426-9391
Product Packaging
| NON-DROWSY SINUS DAYTIME
acetaminophen and phenylephrine hcl tablet |
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| Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498) |
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
