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COLD MULTI-SYMPTOM DAY
Drug Facts
COLD MULTI-SYMPTOM NIGHT
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Topcare for the product Cold Relief Multi-symptom (NDC 36800-250). 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, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
COLD MULTI-SYMPTOM DAY
Drug Facts
COLD MULTI-SYMPTOM NIGHT
Drug Facts
| Active ingredients (in each day caplet) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
| Active ingredients (in each night 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. Severe liver damage may occur if you take
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.
In addition, when using Cold Multi-Symptom Night:
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 the recommended dose (overdose) may cause liver damage. 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, corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
TopCare®
NDC 36800-250-56
Daytime
Nighttime
Cold Multi-Symptom
Pain Reliever/Fever Reducer/Nasal Decongestant
Cough Suppressant/*Antihistamine
Day Non-Drowsy
Contains 3 Medicines:
Fever/Headache/Sore Throat – Acetaminophen
Nasal Congestion – Phenylephrine HCl
Coughing / Dextromethorphan HBr
12 Caplets
Night
*Antihistamine in Nighttime only
Contains 4 Medicines:
Fever/Headache/Sore Throat – Acetaminophen
Nasal Congestion – Phenylephrine HCl
Coughing / Dextromethorphan HBr
Runny Nose – Chlorpheniramine Maleate
8 Caplets
Instant Cooling Sensation
Cool Taste
Quality Guaranteed
Compare to Tylenol® Cold Multi-Symptom Day & Night active ingredients†
* Please review the disclaimer below.