Right Remedies Pain Relief Extra Strength Caplet Tablet, Coated
FDA Label NDC 70692-150
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc. for the product Right Remedies Pain Relief Extra Strength Caplet (NDC 70692-150). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient (in each caplet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Caplet)
Acetaminophen 500mg
Purpose
Pain reliever/fever reducer
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.
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.
Otc - Keep Out Of Reach Of Children
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.
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 |
Other Information
• each caplet contains: sodium 1 mg (very low sodium)
• store at room temperature between 20 - 25°C (68-77°F).
• avoid excessive heat, cold and humidity.
• close cap tightly after use.
Inactive Ingredients
croscarmellose sodium, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone k30, purified water, sodium starch glycolate, starch corn, talc, titanium dioxide
Questions Or Comments?
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Packaging
Strive-150 (7069215005)
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