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| Product NDC Code | 82706-008 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Notts - muscle aches and pain |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET | ||||||
| RxCUI drug identifier | 1148399 | ||||||
| Application Number | M013 | ||||||
| Labeler Name | VIVUNT PHARMA LLC | ||||||
| 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 ingredient (in each caplet) Purpose Acetaminophen 650 mg Pain Reliever/Fever Reducer
| Acetaminophen 650 mg | Pain Reliever/Fever Reducer |
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 1 caplets every 4 to 6 hours do not take more than 6 caplets in 24 hours, or as directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor
| adults and children 12 years and over |
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| children under 12 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Croscarmellose Sodium, Corn Starch, Lactose Monohydrate, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone K30, Sodium Starch Glycolate, 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 For temporary relief of minor aches and pains due to: ● common cold ● headache ● toothache ● muscular aches ● backaches ● premenstrual and menstrual cramps ● minor pain from arthritis Temporarily reduces fever
Purpose
Information about the drug product’s indications for use.Active ingredient (in each caplet) Purpose Acetaminophen 650 mg Pain Reliever/Fever Reducer
| Acetaminophen 650 mg | Pain Reliever/Fever Reducer |
Spl product data elements
Usually a list of ingredients in a drug product.NOTTS - Muscle Aches and Pain Acetaminophen POLYETHYLENE GLYCOL, UNSPECIFIED TALC MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE LECITHIN, SOYBEAN TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN POLYVINYL ALCOHOL, UNSPECIFIED STEARIC ACID SODIUM STARCH GLYCOLATE TYPE A POVIDONE STARCH, CORN Notts;650
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 - 24 Caplets NOTTS™ 8HR* Muscle Aches & Pain Acetaminophen Minor Muscle Aches Fever Reducer Compare to Tylenol® 8HR active ingredients** NDC 82706-008-01 650 mg each caplet 24 CAPLETS Muscle and pain 24-01
PRINCIPAL DISPLAY PANEL - 100 Caplets NOTTS™ 8HR* Muscle Aches & Pain Acetaminophen Minor Muscle Aches Fever Reducer Compare to Tylenol® 8HR active ingredients** NDC 82706-008-02 650 mg each caplet 100 CAPLETS Muscle and pain 100-02
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
* Divided into 2 intakes of one caplet every 4 hours. Use only as directed in Drug Facts. **This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Tylenol® 8HR. Distributed by: VIVUNT PHARMA LLC 8950 SW 74th Court, Suite 1901 Miami, Florida FL 33156-3178 Made in India
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
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 allergic to acetaminophen or any of the inactive 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.
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 lasts more than 10 days pain lasts more than 3 days pain or fever gets worse new symptoms occur redness or swelling is present These could be signs of a serious condition.
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 Store between 20-25°C (68-77°F) Tamper-evident: Do not use if carton is open or if the foil inner seal is broken or missing.
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 damage may occur if you take: ● more than 4,000 mg of acetaminophen in 24 hours, which isthe maximum daily amount. ● 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 rash blisters If a skin reaction occurs, stop use and seek medical attention immediately. 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 allergic to acetaminophen or any of the inactive ingredients. Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain lasts more than 10 days pain lasts more than 3 days pain or fever gets worse new symptoms occur redness or swelling is present 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 Do not exceed recommended dosage. In case of overdose, get medical help or contact a Poison Control Center right away. 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