Otc - Active Ingredient
Active Ingredients (in each caplet)
Acetaminophen 500 mg
The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc. for the product Counteract (NDC 54473-305). 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 Ingredients (in each caplet)
Acetaminophen 500 mg
Purposes
Pain Reliever/fever reducer
Uses
Warnings
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
Do not use
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
Stop use and ask a doctor if:
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: Taking more than the recommended dose (overdose) may cause liver damage. 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
Other information
Inactive ingredients Hypromellose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.
Questions or comments? If you have any questions or comments, or to report and adverse event, please contact 1-800-282-3000.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
* Please review the disclaimer below.