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Tylenol sinus severe, cvp health - Medication Information

Product NDC Code 66715-6557
Drug Name

Tylenol sinus severe, cvp health

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, COATED
RxCUI drug identifier 1243679
Application Number M012
Labeler Name Lil Drug Store Products, Inc
Packages
Package NDC Code Description
66715-6557-2 2 pouch in 1 carton (66715-6557-2) / 2 tablet, coated in 1 pouch
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant
Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
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 do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours swallow whole; do not crush, chew or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor
adults and children 12 years and overtake 2 caplets every 4 hoursswallow whole; do not crush, chew or dissolvedo not take more than 10 caplets in 24 hours
children under 12 yearsask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients carnauba wax, croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sucralose, titanium dioxide, triacetin

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 these symptoms associated with hay fever or other respiratory allergies, and the common cold: sinus congestion and pressure headache nasal congestion minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

Purpose

Information about the drug product’s indications for use.
Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant
Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Spl product data elements

Usually a list of ingredients in a drug product.
Tylenol Sinus Severe, CVP HEALTH Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride CARNAUBA WAX CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE (70000 WAMW) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STARCH, CORN SUCRALOSE TITANIUM DIOXIDE TRIACETIN ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE TYLENOL;1072 Lil Drug Store Tylenol Sinus Severe Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride CARNAUBA WAX CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE (70000 WAMW) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STARCH, CORN SUCRALOSE TITANIUM DIOXIDE TRIACETIN ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE TYLENOL;1072 Tylenol Sinus Severe, TRAVEL BASIX Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride CARNAUBA WAX CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE (70000 WAMW) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STARCH, CORN SUCRALOSE TITANIUM DIOXIDE TRIACETIN ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE TYLENOL;1072 Tylenol Sinus Severe, Lil Drug Store Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride CARNAUBA WAX CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE (70000 WAMW) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STARCH, CORN SUCRALOSE TITANIUM DIOXIDE TRIACETIN ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE TYLENOL;1072

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 Caplet Pouch Carton TYLENOL ® FOR ADULTS SINUS SEVERE Acetaminophen, Phenylephrine HCl, Guaifenesin Pain Reliever–Fever Reducer, Nasal Decongestant, Expectorant SINUS HEADACHE SINUS PRESSURE NASAL CONGESTION MUCUS + CHEST CONGESTION DAY NON-DROWSY 6 Caplets 3 POUCHES OF 2 CAPLETS EACH Lil' DrugStore ® PRINCIPAL DISPLAY PANEL - 6 Caplet Pouch Carton Tylenol Sinus Severe, CVP ® HEALTH, 4ct - PDP/Package TYLENOL ® FOR ADULTS SINUS SEVERE Acetaminophen , Phenylephrine HCl, Guaifenesin Pain Reliever–Fever Reducer, Nasal Decongestant, Expectorant SINUS HEADACHE SINUS PRESSURE NASAL CONGESTION MUCUS + CHEST CONGESTION DAY NON-DROWSY [caplets image] 4 Caplets 2 POUCHES OF 2 CAPLETS EACH [CVP ® HEALTH logo] PDP/Package Tylenol Sinus Severe, TRAVEL BASIX, 4ct - PDP/Package TYLENOL ® FOR ADULTS SINUS SEVERE Acetaminophen , Phenylephrine HCl, Guaifenesin Pain Reliever–Fever Reducer, Nasal Decongestant, Expectorant SINUS HEADACHE SINUS PRESSURE NASAL CONGESTION MUCUS + CHEST CONGESTION DAY NON-DROWSY [caplets image] 4 Caplets 2 POUCHES OF 2 CAPLETS EACH [TRAVEL BASIX logo] PDP/Package Tylenol ® Sinus Severe 25ct, Lil' Drug Store® - PDP/Package TYLENOL ® FOR ADULTS SINUS SEVERE Acetaminophen , Phenylephrine HCI, Guaifenesin Pain Reliever–Fever Reducer, Nasal Decongestant, Expectorant SINUS HEADCHE SINUS PRESSURE NASAL CONGESTION MUCUS + CHEST CONGESTION DAY NON-DROWSY [caplets (2) image] 25 Pouches of 2 Caplets each [Lil' Drug Store ® logo] PDP/Package Tylenol ® Sinus Severe 30ct, Lil' Drug Store ® - PDP/Package TYLENOL ® FOR ADULTS SINUS SEVERE Acetaminophen , Phenylephrine HCI, Guaifenesin Pain Reliever–Fever Reducer, Nasal Decongestant, Expectorant SINUS HEADCHE SINUS PRESSURE NASAL CONGESTION MUCUS + CHEST CONGESTION DAY NON-DROWSY [caplets (2) image] 30 Pouches of 2 Caplets each [Lil' Drug Store ® logo] PDP/Package

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 Product distributed by: JOHNSON & JOHNSON CONSUMER INC. McNeil Consumer Healthcare Division, Fort Washington, PA 19034 USA Repackaged and distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW Cedar Rapids, IA 52402

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 high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus)

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. if you have ever had an allergic reaction to this product or any of its 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.

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 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

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, 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 occurs with rash or headache that lasts 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 dose

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 each caplet contains: sodium 3 mg store between 20-25°C (68-77°F) do not use if pouch is torn or damaged

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. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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. if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur 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 occurs with rash or headache that lasts 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. 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.

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