FDA Label for Up And Up Daytime Vapor Ice Cold And Flu Nighttime Vapor Ice Cold And Flu
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH CAPLET) DAYTIME
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- ACTIVE INGREDIENTS (IN EACH CAPLET) NIGHTTIME
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Up And Up Daytime Vapor Ice Cold And Flu Nighttime Vapor Ice 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) Daytime
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
• nasal congestion• sinus congestion and pressure• cough due to minor throat and bronchial irritation• minor aches and 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• nasal congestion• sinus congestion and pressure• cough due to minor throat and bronchial irritation• cough to help you sleep• minor aches and pains• headache• fever• sore throat• runny nose and sneezing• reduces swelling of nasal passages• temporarily restores freer breathing through the nose• promotes nasal and/or sinus drainage
temporarily relieves common cold/flu symptoms:
Warnings
Liver warning: This product contains 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 this product• skin reddening• blisters• rash• more than 4,000 mg of acetaminophen in 24 hours• with other drugs containing acetaminophen• 3 or more alcoholic drinks every day while using this product• skin reddening• blisters• rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.• 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• 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
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• cough that occurs with too much phlegm (mucus)• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema• liver disease• heart disease• thyroid disease• diabetes• glaucoma• cough that occurs with too much phlegm (mucus)• a breathing problem such as emphysema or chronic bronchitis• trouble urinating due to an enlarged prostate gland• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
• taking sedatives or tranquilizers• taking the blood thinning drug warfarin
When Using This Product
do not use more than directed
• 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
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.• 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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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.
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
• take only as directed - see overdose warning• do not exceed 8 caplets per 24 hrs• take only as directed - see overdose warning• do not exceed 8 caplets per 24 hrs
adults & children 12 yrs & over | 2 caplets 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 caplets with water every 4 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
Other Information
• each caplet contains: sodium 3 mg• store at 20-25°C (68-77°F)• store at 20-25°C (68-77°F)
Inactive Ingredients
croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
Questions?
Call 1-888-547-7400
Call 1-888-547-7400
Active Ingredients (In Each Caplet) Nighttime
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Package/Label Principal Display Panel
Compare to active ingredients in Vicks® DayQuil® Severe+ VapoCOOL™
daytime
vapor ice™
cold and flu
MAX STRENGTH
acetaminophen (pain reliever/fever reducer)
phenylephrine HCl (nasal decongestant)
dextromethorphan HBr (cough suppressant)
guaifenesin (expectorant)
minor aches and pains, fever
nasal congestion and sinus pressure
cough, chest congestion
16 CAPLETS
ACTUAL SIZE
Compare to active ingredients in Vicks® NyQuil® Severe+ VapoCOOL™
value pack
nighttime
vapor ice™
cold and flu
MAX STRENGTH
acetaminophen (pain reliever/fever reducer)
phenylephrine HCl (nasal decongestant)
doxylamine succinate (antihistamine)
dextromethorphan HBr (cough suppressant)
minor aches and pains, fever
nasal congestion and sinus pressure
sneezing, runny nose, cough
8 CAPLETS
ACTUAL SIZE
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