Regular Strength Pain Reliever
FDA Label NDC 68210-5016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Regular Strength Pain Reliever (NDC 68210-5016). 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 tablet), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Acetaminophen 325 mg
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.
Otc - Do Not Use
Do not use• with any other drug containing acetaminophen (prescription or non prescription). 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 in this product
Otc - Ask Doctor
Ask a doctor before use if the user hasliver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the user istaking the blood thinning drug warfarin
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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.
Directions
do not take more than directed (see overdose warning)
| adults & children 12 years & over | • take 2 tablets every 4 to 6 hours while symptoms last
• do not take more than 10 tablets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor |
| children 6 years to under 12 years | • take 1 tablet every 4 to 6 hours while symptoms last
• do not take more than 5 tablets in 24 hours • do not use for more than 5 days unless directed by a doctor |
| children under 6 years | ask a doctor |
Other Information
• store between 20–25°C (68–77°F)
Inactive Ingredients
hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, pre-gelatinized starch, stearic acid, talc, titanium dioxide
Questions Or Comments?
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Distributed By:
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779
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