Day Severe Cold And Flu
DAY SEVERE COLD AND FLU
Day-night Severe Cold And Flu
FDA Label NDC 11822-8554
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product Day-night Severe Cold And Flu (NDC 11822-8554). 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 day severe cold and flu, otc - active ingredient, inactive ingredient, otc - purpose, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
DAY -EACH SOFTGEL CONTAINS
ACETAMINOPHEN 325MG
D0EXTROMETHORHAN HBR10 MG,
GUAIFENESIN 200 MG
PHENYLEPHRINE HCL 5 MG
(in each softgel)
- Acetaminophen 325mg
- Dextromethorphan HBR 10 mg
- Doxylamine Succinate 6.25 mg
- PhenylephrineHCl 5 mg
Inactive Ingredient
FD&C Blue No.1,FD&C Red No. 40, 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
Otc - Purpose
PAIN RELIEVER-FEVER REDUCER
COUGH SUPPRESENT
EXPECTORANT
NASAL DECONGESTANT
Purpose;
Minor Aches & Pains
Nasal/Sinus Congestion
& Sinus Pressure
Sneezing, Runny Nose
Cough
Indications & Usage
temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion & pressure
- cough due to minor throat & bronchial irritation
- minor aches & pains
- headache
- fever
- sore throat
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Pain reliever/Fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Dosage & Administration
Directions
take only as directed - do not exceed 8 Softgels per 24 hrs -
- 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 2 softgels with water every 6 hrs -
- children 4 to under 12 yrs ask a doctor -
- children under 4 yrs do not use
Directions
take only as directed - do not exceed 8 softgels per 24 hours -
Warnings
Warnings This product contains acetaminophen. Severe liver damage may occur if you take more than 8 LiquiCaps in 24 hrs, which is the maximum daily amount for this product
Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: Skin reddening
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 Warnings
This product contains acetaminophen. Severe liver damage may occur if you take more than 8 softgels in 24 hrs, which is the maximum daily amount for this product
Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: Skin reddening
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. |
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Overdose warning 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. (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. |
Night Severe Cold And Flu
NIGHT SEVERE COLD AND FLU
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