FDA Label for Nighttime Severe Cold And Flu
View Indications, Usage & Precautions
Nighttime Severe Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Kroger. 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.
Otc - Active Ingredient
- Acetaminophen
- PhenylephrineHCl,
- Doxylamine Succinate
- Dextromethorphan HBr
Inactive Ingredient
FD&C BLUE #1, GELATN, GLYCERIN, POLYETHYLENE GLYCOL, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SHELLAC, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE
Otc - Purpose
- Pain reliever/Fever reducer
- Cough suppressant
- Antihistamine
- Nasal decongestant
Indications & Usage
temporarily relieves common cold/flu symptoms:
nasal congestion
sinus congestion & pressure
cough due to minor throat & bronchial irritation
cough to help you sleep
minor aches & pains
headache
fever
sore throat
runny nose & sneezing
reduces swelling of nasal passages
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
Dosage & Administration
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
Otc - Keep Out Of Reach Of Children
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.
Warnings
Liver warning
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
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
Allergy Alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
Skin reddening
Blisters
Rash
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.
* Please review the disclaimer below.