Active Ingredient (In Each Tablet) ..................................................... Purpose
Acetaminophen 500 mg .....................................................................................pain reliever/fever reducer
Non-aspirin Acetaminophen
FDA Label NDC 71105-210
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Redicare Llc for the product Non-aspirin Acetaminophen (NDC 71105-210). 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 active ingredient (in each tablet) ..................................................... purpose, uses:, warnings:, do not use:, stop use and ask a doctor if, if pregnant or breast-feeding a baby,, keep out of reach of children., directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses:
temporarily relieves minor aches and pains associated with ■ a headache ■ colds ■ a toothache ■ minor arthritis pain ■ muscular aches ■ menstrual cramps ■ a backache
Warnings:
Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if: ■ you take more than 8 tablets in 24 hours ■ you take with other drugs containing acetaminophen (prescription or non-prescription) ■ you have 3 or more alcoholic drinks every day while using this product.
Do Not Use:
■ with any other product containing acetaminophen ■ for more than 10 days for pain unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor
Stop Use And Ask A Doctor If
■ symptoms do not improve ■ pain or fever persists or gets worse ■ new symptoms occur ■ redness or swelling is present
If Pregnant Or Breast-Feeding A Baby,
ask a health professional before use.
Keep Out Of Reach Of Children.
In a 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.
Directions:
Adults and children 12 years of age or older: Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor
Children under 12 years of age:
Do not use this product: this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.
Other Information:
■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) • Avoid excessive heat and humidity
Inactive Ingredients:
corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid
Package Label.Principal Display Panel
Non Aspirin (Non Aspirin Box 65829)
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