Other
Drug Facts
DISTRIBUTED BY
SPIRIT PHARMACEUTICALS LLC.
RONKONKOMA, NY 11779
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Regular Strength Pain Relief (NDC 68210-0120). 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 other, active ingredient (in each softgel), purpose, uses, liver warning, allergy alert, do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
DISTRIBUTED BY
SPIRIT PHARMACEUTICALS LLC.
RONKONKOMA, NY 11779
Acetaminophen 325 mg
Pain reliever/fever reducer
This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Ask a doctor before use if the user has liver disease
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
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.
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.
| adults and children 12 years and over |
|
| children 6-11 years |
|
| children under 6 years | ask a doctor |
FD&C red # 40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Call 1-888-333-9792
* Please review the disclaimer below.