The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product Fast Dissolving Daytime - Nighttime Cold And Flu (NDC 11822-7859). 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 otc - active ingredient, indications & usage, warnings, inactive ingredient, dosage & administration, otc - keep out of reach of children, otc - purpose, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each softgel) ACETAMINOPHEN 325MG DEXTROMETHORHAN HBR10 MG, GUAIFENESIN 200 MG , PHENYLEPHRINE HCL 5 MG |
(in each softgel) Acetaminophen 325mg Dextromethorphan HBR 10 mg Doxylamine Succinate 6.25 mg PhenylephrineHCl 5mg |
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Purpose
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Warnings
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. |
Warnings
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.
FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide |
FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide |
Do not take more than directed (See Overdose warning section) - do not exceed 12 Softgels per 24 hr period
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Directions
take only as directed - do not exceed 8 softgels per 24 hours -
adults & children 12 yrs & over 2 softgels with water every 6 hrs -
children 4 to under 12 yrs ask a doctor -
children under 4 yrs do not use
Keep out of reach of children. Overdose warning: 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. (1800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. |
Keep out of reach of children. Overdose warning 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 |
PAIN RELIEVER-FEVER REDUCER
COUGH SUPPRESENT
MINOR ACHES AND PAINS
CHEST CONGESTION
MINOR ACHES AND PAINS, FEVER
NASAL CONGESTION AND SINUS PRESSURE
SNEEZING, RUNNY NOSE
COUGH
PAIN RELIEVER-FEVER REDUCER
COUGH SUPPRESENT
MINOR ACHES AND PAINS
NASAL DECONGESTION
24 Count (630t)
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