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| Product NDC Code | 66715-9744 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Lil drug store multi-symptom sinus relief |
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| Type | Brand | ||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET | ||||||
| RxCUI drug identifier | 1243679 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | Lil' Drug Store Products, Inc. | ||||||
| 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 tablet) Purpose Acetaminophen 325 mg Pain reliever Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant
| Acetaminophen 325 mg | Pain reliever |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
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 adults and children 12 years and over take 1-2 tablets every 4 hours as needed do not take more than 12 tablets in 24 hours, or as directed by a doctor children under 12 years consult a doctor
| adults and children 12 years and over |
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| children under 12 years |
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients corn starch may contain , croscarmellose sodium , FD&C red #40 , hypromellose , maltodextrin , microcrystalline cellulose, polyethylene glycol , povidone , sodium starch glycolate , starch , stearic acid
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 For the temporary relief of: sinus congestion and pressure nasal congestion headache minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily relieves nasal congestion due to the common cold, and hay fever and other upper respiratory allergies
Purpose
Information about the drug product’s indications for use.Active ingredients (in each tablet) Purpose Acetaminophen 325 mg Pain reliever Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant
| Acetaminophen 325 mg | Pain reliever |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
Spl product data elements
Usually a list of ingredients in a drug product.Lil Drug Store Multi-Symptom Sinus Relief Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride STARCH, CORN CROSCARMELLOSE SODIUM FD&C RED NO. 40 HYPROMELLOSE, UNSPECIFIED MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FR14 Lil Drug Store Multi-Symptom Sinus Relief Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride STARCH, CORN CROSCARMELLOSE SODIUM FD&C RED NO. 40 HYPROMELLOSE, UNSPECIFIED MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE AZ;286
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.PRINCIPAL DISPLAY PANEL - 6 Tablet Pouch Carton - 9744 Compare to the active ingredients in Tylenol ® Sinus Congestion & Pain Severe* Multi-Symptom Sinus Relief NON-DROWSY Pain Reliever, Nasal Decongestant, Expectorant SEVERE CONGESTION Contains 3 Active Medicines: Acetaminophen...relieves Headache Guaifenesin...relieves Chest Congestion Phenylephrine HCl...relieves Nasal Congestion & Sinus Pressure 6 TABLETS Lil' DrugStore ® Principal Display Panel - 6 Tablet Pouch Carton - 9744
PRINCIPAL DISPLAY PANEL - 6 Tablet Pouch Carton - 9844 Compare to the active ingredients in Tylenol ® Sinus Congestion & Pain Severe* Multi-Symptom Sinus Relief NON-DROWSY Pain Reliever, Nasal Decongestant, Expectorant SEVERE CONGESTION Contains 3 Active Medicines: Acetaminophen...relieves Headache Guaifenesin...relieves Chest Congestion Phenylephrine HCl...relieves Nasal Congestion & Sinus Pressure 6 TABLETS Lil' DrugStore ® Principal Display Panel - 6 Tablet Pouch Carton - 9844
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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 thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
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
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. 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.
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. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Prompt 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? call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)
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 pain, nasal congestion or cough 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 is accompanied by a fever, rash or persistent headache nervousness, dizziness or sleeplessness occur. These could be signs of a serious condition.
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 this product do not exceed recommended dosage.
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 do not use if carton or inner pouch is open or torn store at room temperature 59-86°F (15-30°C) avoid excessive heat and humidity see bottom panel of carton or pouch for expiration date and lot number
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 This product contains 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 this product. 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. 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. Ask a doctor before use if you have liver disease heart disease diabetes thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage. Stop use and ask a doctor if pain, nasal congestion or cough 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 is accompanied by a fever, rash or persistent headache nervousness, dizziness or sleeplessness occur. 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. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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