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Multi-symptom sinus severe congestion - Medication Information

Product NDC Code 66715-9721
Drug Name

Multi-symptom sinus severe congestion

Type Brand
Pharm Class Adrenergic alpha1-Agonists [MoA],
Decreased Respiratory Secretion Viscosity [PE],
Expectorant [EPC],
Increased Respiratory Secretions [PE],
alpha-1 Adrenergic Agonist [EPC]
Active Ingredients
Acetaminophen 325 mg/1
Guaifenesin 200 mg/1
Phenylephrine hydrochloride 5 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 1243679
Application Number part341
Labeler Name Lil' Drug Store Products, Inc.
Packages
Package NDC Code Description
66715-9721-7 50 pouch in 1 carton (66715-9721-7) / 2 tablet in 1 pouch
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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
Active ingredients (in each tablet)Purpose
Acetaminophen 325 mgPain reliever
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal 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 of age consult a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients FD&C red #40, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide may contain , 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, 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
Active ingredients (in each tablet)Purpose
Acetaminophen 325 mgPain reliever
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Spl product data elements

Usually a list of ingredients in a drug product.
Multi-Symptom Sinus Severe Congestion Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride FD&C RED NO. 40 MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A CORN STARCH, CORN STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FR14

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 - 2 Tablet Packet Carton Lil' DrugStore ® Just what you need. SM Convenient-Sized Relief Multi-Symptom Sinus Acetaminophen, Guaifenesin, Phenylephrine HCl SEVERE CONGESTION Non-Drowsy Relief of Chest Congestion Nasal Congestion Sinus Pressure 50 PACKETS OF 2 TABLETS 27217 PRINCIPAL DISPLAY PANEL - 2 Tablet Packet Carton

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 feeding
If 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 store at room temperature 59-86°F (15-30°C) avoid excessive heat and humidity

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. 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. 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