FDA Label for Daytime Non Drowsy Cold And Flu And Nighttime Cold And Flu

View Indications, Usage & Precautions

Daytime Non Drowsy Cold And Flu And Nighttime Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals Llc. 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.

Uses



  • temporarily relieves common cold/flu symptoms:
  • fever
  • headache
  • sore throat
  • minor aches and pain
  • cough due to minor throat and bronchial iffitation
  • nasal congestion (Daytime only)
  • runny nose and sneezing (Nighttime only)

Warnings



Liver warningThis product contains acetaminophen. Severe liver damage may occur if you take: ● more than 4 doses in 24 hours, 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 warningIf 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.


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.

● if you have ever had an allergic reaction to this product or any of its ingredients

● to make a child sleepy (Nighttime only)


Ask A Doctor Before Use If You Have



● cough that occurs with too much phlegm (mucus) ● liver disease
● trouble urinating due to enlarged prostate gland
● diabetes (Daytime only) ● heart disease (Daytime only)
● thyroid disease (Daytime only) ● high blood pressure (Daytime only)
● persistent or chronic cough such as occurs with smoking, asthma, 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)


Ask A Doctor Or Pharmacist Before Use If You Are



● taking the blood thinning drug warfarin
● taking sedatives or tranquilizers (Nighttime only)


Stop Use And Ask A Doctor If



● you get nervous, dizzy or sleepless (Daytime only)
● pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only)
● pain or cough gets worse or lasts more than 7 days (Nighttime only)
● 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.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdosage



Overdose warningTaking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.


Other Information



  • store at room temperature.

Inactive Ingredients



DAYTIME

FD&C Red# 40, FD&C Yellow# 6, gelatin, glycerin, polyethylene glycol, lecithin, myglyol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

NIGHTTIME

D&C Yellow# 10, FD&C Blue# 1, gelatin, glycerin, myglyol, lecithin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, polysorb, sorbitol sorbitan, titanium dioxide


Questions Or Comments?



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