Otc - Active Ingredient
Active ingredient (in each caplet)
Acetaminophen 650 mg
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Arthritis Pain Reliever (NDC 0363-9781). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each caplet)
Acetaminophen 650 mg
Purpose
Pain reliever/fever reducer
Uses
• temporarily relieves minor aches and pains due to:
o minor pain of arthritis
o muscular aches
o backache
o premenstrual and menstrual cramps
o the common cold
o headache
o toothache
• temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 6 caplets in 24 hours, which is the 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
• 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 are allergic to acetaminophen or any of the inactive ingredients in this product
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 (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
adults |
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| under 18 years of age |
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Other information
• store between 20-25°C (68-77°F)
• The FDA approved Dissolution methods differ from USP
Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, povidone, pregelatinized starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, triacetin
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