FDA Label for Up And Up Daytime Severe Cold Nighttime Cold And Flu

View Indications, Usage & Precautions

Up And Up Daytime Severe Cold Nighttime Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product Target 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 Caplet) - Day Time Severe Cold



Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg


Active Ingredients (In Each Caplet) – Night Time Cold & Flu



Acetaminophen 325 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 5 mg


Purposes - Day Time Severe Cold



Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant


Purposes - Night Time Cold & Flu



Pain reliever/fever reducer

Antihistamine

Nasal decongestant


Uses



  • •temporarily relieves these common cold and flu symptoms:
  • •nasal congestion
  • •cough (DAY TIME Severe Cold only)
  • •minor aches and pains
  • •headache
  • •sore throat
  • •runny nose and sneezing (NIGHT TIME Cold & Flu only)
  • •helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME Severe Cold only)
  • •temporarily reduces fever

Warnings



Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take

  • •more than 4,000 mg of acetaminophen in 24 hours
  • •with other drugs containing acetaminophen
  • •3 or more alcoholic drinks every day while using these products
  • 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.


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.
  • •with any other product containing diphenhydramine, even one used on skin (NIGHT TIME Cold & Flu only)
  • •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 these products.
  • •if you have ever had an allergic reaction to these products or any of their ingredients

Ask A Doctor Before Use If You Have



  • •liver disease
  • •heart disease
  • •high blood pressure
  • •thyroid disease
  • •diabetes
  • •trouble urinating due to an enlarged prostate gland
  • •glaucoma (NIGHT TIME Cold & Flu only)
  • •a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME Cold & Flu only)
  • •persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (DAY TIME Severe Cold only)
  • •cough that occurs with too much phlegm (mucus) (DAY TIME Severe Cold only)

Ask A Doctor Or Pharmacist Before Use If You Are



  • •taking the blood thinning drug warfarin
  • •taking sedatives or tranquilizers (NIGHT TIME Cold & Flu only)

When Using These Products



  • •do not use more than directed
  • •excitability may occur, especially in children (NIGHT TIME Cold & Flu only)
  • •marked drowsiness may occur (NIGHT TIME Cold & Flu only)
  • •alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME Cold & Flu only)
  • •avoid alcoholic drinks (NIGHT TIME Cold & Flu only)
  • •be careful when driving a motor vehicle or operating machinery (NIGHT TIME Cold & Flu only)

Stop Use And Ask A Doctor If



  • •nervousness, dizziness, or sleeplessness occur
  • •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. (DAY TIME Severe Cold only)

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



Overdose warning: 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



  • •do not take more than directed (see Overdose warning)
  • •do not take more than 10 caplets in any 24-hour period
  • •adults and children 12 years of age and older: take 2 caplets every 4 hours
  • •children under 12 years of age: do not use

Other Information



  • •each caplet contains: sodium 4 mg (DAY TIME Severe Cold only)
  • •store at 20-25°C (68-77°F)

Inactive Ingredients (Day Time Severe Cold)



croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide


Inactive Ingredients (Night Time Cold & Flu)



crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide


Questions?



Call 1-888-547-7400


Principal Display Panel



Compare to active ingredients in Mucinex® Fast-Max® Day Time Severe Cold

see new warnings

maximum strength

daytime severe cold

acetaminophen (pain reliever/fever reducer)

dextromethorphan HBr (cough suppressant)

guaifenesin (expectorant)

phenylephrine HCl (nasal decongestant)

relieves headache, fever and sore throat

relieves nasal and chest congestion

controls cough

thins and loosens mucus

ACTUAL SIZE

AGES 12+ YEARS

20 CAPLETS

Compare to active ingredients in Mucinex® Fast-Max® Night Time Cold & Flu

see new warnings

maximum strength

nighttime cold and flu

acetaminophen (pain reliever/fever reducer)

diphenhydramine HCl (antihistamine)

phenylephrine HCL (nasal decongestant)

relieves headache, fever and sore throat

relieves nasal congestion

relieves sneezing and runny nose

ACTUAL SIZE

AGES 12+ YEARS

10 CAPLETS


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