FDA Label for Sever Daytime Cold And Flu And Sever Nighttime Cold And Flu
View Indications, Usage & Precautions
Sever Daytime Cold And Flu And Sever Nighttime Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Kmart Corporation. 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.
Active Ingredients (In Each Softgel)
DAYTIME SEVERE COLD AND FLU
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5mg
NIGHTTIME SEVERE COLD AND FLU
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5mg
Purpose
DAYTIME SEVERE COLD AND FLU
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Purposes
NIGHTTIME SEVERE COLD AND FLU
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses
- temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion & pressure
- cough due to minor throat & bronchial irritation
- cough to help you sleep (Nighttime only)
- minor aches & pains
- headache
- fever
- sore throat
- runny nose & sneezing (Nighttime only)
- 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
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses 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
- skin reddening
- blisters
- rash
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.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Do Not Use
- with any other drug containing acetaminophen (prescription or nonprescription).
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. - if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- to make a child sleep (Nighttime only)
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Daytime only)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
- glaucoma （Nighttime only）
When Using This Product
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Nighttime only:
Stop Use And Ask A Doctor If
- you get nervous, dizzy or sleepless
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
Overdose Warning
Taking more than directed can cause serious health problems. 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.
Directions
- take only as directed - see Overdose warning
- do not exceed 4 doses per 24 hrs
- when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
adults & children 12 yrs and over | 2 softgels with water every 4 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
Other Information
- store at room temperature 15°-30°C (59°-86°F)and avoid excessive heat
Inactive Ingredients
DAYTIME SEVERE COLD AND FLU
FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, and white edible ink
NIGHTTIME SEVERE COLD AND FLU
FD&C blue #1, D&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, and white edible ink
Questions Or Comments?
Call toll free: 1-800-842-7886
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severe daytime cold & flu and severe nighttime cold & flu 24ct
NDC 49738-036-04
*Compare to the active ingredients in Vicks® DayQuil® Severe and NyQuil® Severe Cold and Flu
* Please review the disclaimer below.