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Product NDC Code | 70692-150 | ||||||||||
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Drug Name | Right remedies pain relief extra strength caplet |
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Type | Brand | ||||||||||
Active Ingredients |
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Route | ORAL | ||||||||||
Dosage Form | TABLET, COATED | ||||||||||
RxCUI drug identifier | 198440 | ||||||||||
Application Number | M013 | ||||||||||
Labeler Name | Strive Pharmaceuticals 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 Ingredient (in each caplet) Acetaminophen 500mg
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 adult & children 12 years of age and over • take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours unless directed by a doctor • do not take more than 10 days, unless directed by a doctor children under 12 years of age • ask a doctor
adult & children 12 years of age and over | |
children under | • ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients croscarmellose sodium, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone k30, purified water, sodium starch glycolate, starch corn, 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 minor aches and pains due to: • the common cold • headache • backache • minor pain of arthritis • toothache • muscular aches • premenstrual and menstrual cramps • temporarily reduces fever.
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/fever reducer
Spl product data elements
Usually a list of ingredients in a drug product.RIGHT REMEDIES Pain Relief Extra Strength Caplet Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE K30 WATER SODIUM STARCH GLYCOLATE TYPE A STARCH, CORN TALC TITANIUM DIOXIDE S150
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.Packaging Strive-150 strive-150
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
*compare to the active ingredient of Extra Strength Tylenol ® TAMPER EVIDENT. DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE Distributed by: Strive Pharmaceuticals inc. East Brunswick, NJ 08816 Product of India Packaged & Quality Assured in USA READ AND KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol ® Extra Strength Caplets. REV.00- 102022
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. Prompt medical attention is critical for adults as well as 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? 1-888-577-8033 Monday - Friday 8am - 4pm EST
Storage and handling
Information about safe storage and handling of the drug product.Other information • each caplet contains : sodium 1 mg (very low sodium) • store at room temperature between 20 - 25ºC (68-77ºF). • avoid excessive heat, cold and humidity. • close cap tightly after use.
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 have ever had an allergic reaction to this product or any of its 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 gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • 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: 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 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