Other
Drug Facts
Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779
The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Maximum Strength Mucus Relief Plus Pain And Headache (NDC 83059-0052). 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, 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.
Drug Facts
Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779
Acetaminophen 325 mg
Guaifenesin 200 mg
Pain reliever/fever reducer
Expectorant
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take:
while using this product
Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
When using this product do not use more than directed
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
1-800-373-6981 (toll-free)
FD&C blue no. 1, gelatin, glycerin, hypromellose, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
* Please review the disclaimer below.