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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Inc. for the product Cold And Flu (NDC 55910-862). 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, allergy alert, sore throat warning, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
| Active ingredients (in each softgel) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
This product contains acetaminophen. Severe liver damage may occur if you take
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
When using this product, do not use more than directed.
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.
Taking more than directed can cause serious health problems. 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.
FD&C Yellow # 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
1-888-309-9030
Compare to active ingredients in Maximum Strength MUCINEX® FAST-MAX® COLD & FLU ALL IN ONE*
MAXIMUM STRENGTH
Cold & Flu
ACETAMINOPHEN/ PAIN RELIEVER/ FEVER REDUCER
DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT
GUAIFENESIN/ EXPECTORANT
PHENYLEPHRINE HCL/NASAL DECONGESTANT
DISSOLVES QUICKLY
Temporarily Relieves headache, fever, sore throat,
minor aches & pains, cough, chest congestion,
nasal/sinus congestion & sinus pressure
20 Softgels
* Please review the disclaimer below.