FDA Label for Day-night Severe Cold And Flu
View Indications, Usage & Precautions
Day-night Severe Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Rite Aid. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Day Severe Cold And Flu
DAY SEVERE COLD AND FLU
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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