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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Cold Plus Head Congestion Nighttime (NDC 36800-925). 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 caplet) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Chlorpheniramine maleate 2 mg | Antihistamine |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| 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
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.
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 under 12 years |
|
acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
NDC 36800-925-02
For Adults
TopCare® Health™
Nighttime
Cold + Head Congestion Nighttime
Pain Reliever/Fever Reducer - Acetaminophen
Cough Suppressant – Dextromethorphan HBr
Nasal Decongestant - Phenylephrine HCl
Antihistamine – Chlorpheniramine Maleate
Relief of:
Headache + Body Aches
Fever + Sore Throat • Cough
Nasal Congestion • Runny Nose
Pharmacists Recommend
24 Cool Taste Caplets
* Please review the disclaimer below.