Other
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Marc Glassman, Inc. for the product Severe Cold Head Congestion (NDC 68998-175). 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, otc - purpose, uses, liver warning, sore throat warning, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
| Active ingredients (in each caplet) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
If sore throat is severe, perists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
When using this product do not exceed recommended dosage
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
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 under 12 years |
|
acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
68998-175-02
†Compare to the active ingredients in Tylenol® Cold Head Congestion Severe
Marc’s®
Severe
Cold Head Congestion
For Adults
Pain Reliever/Fever Reducer, Nasal Decongestant, Expectorant
Acetaminophen, Phenylephrine HCl, Guaifenesin
For Relief Of:
• Headache & Fever
• Stuffy Nose & Sinus Pressure
• Chest Congestion, Clears Out Mucus
24 Cool Taste Caplets
* Please review the disclaimer below.