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| Product NDC Code | 30142-688 | ||||
|---|---|---|---|---|---|
| Drug Name | Sinus relief |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1046751, 1243679, 2634818 |
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| Application Number | part341 | ||||
| Labeler Name | Kroger Company | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each caplet) – SINUS RELIEF Day Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Active ingredients (in each caplet) – SINUS RELIEF Night Acetaminophen 325 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 5 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions • do not take more than directed (see Overdose warning) • do not take more than 10 caplets in any 24-hour period • adults and children 12 years and older: take 2 caplets every 4 hours • children under 12 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients (SINUS RELIEF Day only) croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
Inactive ingredients (SINUS RELIEF Night only) crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses • temporarily relieves: • nasal congestion • headache • minor aches and pains • sinus congestion and pressure • runny nose and sneezing (SINUS RELIEF Night only) • temporarily promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (SINUS RELIEF Day only)
Purpose
Information about the drug product’s indications for use.Purpose – SINUS RELIEF Day Pain reliever Expectorant Nasal decongestant
Purpose – SINUS RELIEF Night Pain reliever Antihistamine Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Sinus Relief Acetaminophen, guaifenesin, diphenhydramine HCl, phenylephrine HCl Sinus Relief Acetaminophen, guaifenesin, phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSCARMELLOSE SODIUM CROSPOVIDONE (15 MPA.S AT 5%) MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE L145 Sinus Relief Acetaminophen, diphenhydramine HCl, phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSPOVIDONE (15 MPA.S AT 5%) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE L625
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package/Label Principal Display Panel – SINUS RELIEF Day COMPARE TO the active ingredients of MUCINEX ® SINUS-MAX ® See side panel FOR AGES 12+ MAXIMUM STRENGTH Sinus Relief Acetaminophen, Pain Reliever Guaifenesin, Expectorant Phenylephrine HCl, Nasal Decongestant Day Time Relieves Sinus Pressure, Headache & Congestion Thins & Loosens Mucus actual size 10 CAPLETS SEE NEW WARNINGS
Package/Label Principal Display Panel – SINUS RELIEF Night COMPARE TO the active ingredients of MUCINEX ® SINUS-MAX ® See side panel FOR AGES 12+ MAXIMUM STRENGTH Sinus Relief Acetaminophen, Pain Reliever Diphenhydramine HCl, Antihistamine Phenylephrine HCl, Nasal Decongestant Night Time Relieves Nasal Congestion, Sinus Pressure & Pain Relieves Runny Nose & Sneezing 10 CAPLETS actual size SEE NEW WARNINGS Kroger Sinus Relief Day Time Night Time image 1 Kroger Sinus Relief Day Time Night Time image 2
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have • liver disease • heart disease • diabetes • high blood pressure • thyroid disease • trouble urinating due to an enlarged prostate gland • glaucoma (SINUS RELIEF Night only) • a breathing problem such as emphysema or chronic bronchitis (SINUS RELIEF Night only) • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (SINUS RELIEF Day only) • cough that occurs with too much phlegm (mucus) (SINUS RELIEF Day only)
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers (SINUS RELIEF Night only)
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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 (SINUS RELIEF Night only) • 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 these products. • if you have ever had an allergic reaction to these products or any of their ingredients
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-632-6900
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • pain, cough or nasal congestion gets worse or lasts more than 7 days • 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 persistent headache. These could be signs of a serious condition. (SINUS RELIEF Day only)
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using these products • do not use more than directed • excitability may occur, especially in children (SINUS RELIEF Night only) • marked drowsiness may occur (SINUS RELIEF Night only) • alcohol, sedatives, and tranquilizers may increase drowsiness (SINUS RELIEF Night only) • avoid alcoholic drinks (SINUS RELIEF Night only) • be careful when driving a motor vehicle or operating machinery (SINUS RELIEF Night only)
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information • each caplet contains: sodium 4 mg (SINUS RELIEF Day only) • store at 20-25 ° C (68-77 ° F)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using these products Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API