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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 Goodsense for the product Cold Multi-symptom Daytime And Nighttime (NDC 50804-551). 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.
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
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.
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.
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, 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 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
GoodSense
NDC 50804-551-02
Pain Relief
Cold Daytime & Nighttime
Multi-Symptom For Adults
Cool Taste
Instant Cooling Sensation
• Head & Body Aches
• Fever, Sore Throat
• Nasal Congestion
• Cough
• Runny Nose*
Pain Reliever•Fever Reducer/Acetaminophen
Nasal Decongestant/Phenylephrine HCl
Cough Suppressant/Dextromethorphan HBr
Antihistamine*/Chlorpheniramine Maleate*
*Antihistamine in Nighttime Only
20 CAPLETS
12 Daytime / 8 Nighttime Caplets
Compare to active ingredients of Tylenol® Cold Multi-Symptom Day & Night†
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* Please review the disclaimer below.