Nighttime Severe Cold & Flu Active Ingredients (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Phenylephinr HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Yet Health Group Llc for the product Severe Daytime Nighttime Cold And Flu Relief (NDC 81179-804). 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 nighttime severe cold & flu active ingredients (in each softgel), daytime severe cold & flu active ingredients (in each softgel), nighttime severe cold & flu purpose, daytime severe cold & flu purpose, nighttime severe cold & flu uses, daytime severe cold & flu uses, warnings, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Phenylephinr HCl 5 mg
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Temporarily relieves common cold/flu symptoms:
Temporarily relieves common cold/flu symptoms:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: 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.
taking the blood thinning drug warfarin.
do not use more than directed.
These could be signs of a serious condition.
These could be signs of a serious condition.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
adults & children 12 yrs & over | 2 softgels with water every 4 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
| adults & children 12 yrs & over ..........................take 2 softgels with water every 4 hrs | |
| children 4 to under 12 yrs ...................................ask a doctor | |
| children under 4 yrs ................................................do not use |
D&C YELLOW #10, FD&C BLUE #1, GELATIN, GLYCERIN, POLYETHYLENE GLYCOL, POLYSORBATE, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SODIUM HYDROXIDE, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE.
FD&C YELLOW #6, GELATIN, GLYCERIN, POLYETHYLENE GLYCOL, POLYSORBATE, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE.
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