DAYTIME and Nighttime Cold and Flu Dailymed
Generic: acetaminophen, dextromethorphan hydrobromide,guaifenesin, phenylephrine hydrochloride / acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride is used for the treatment of Cough Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Headache Sleep Initiation and Maintenance Disorders Rhinitis, Allergic, Perennial Bronchitis Common Cold Laryngitis Pharyngitis Sinusitis Whooping Cough Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular
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Daytime Cold And Flu
Otc - Active Ingredient Section
Drug Facts
OTC - PURPOSE SECTION
Active ingredients (in each softgel)Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Purposes Acetaminophen 325 mg............................Pain reliever/fever reducer Dextromethorphan HBr 10 mg.............................Cough suppressant Guaifenesin 200 mg.........................................................Expectorant Phenylephrine HCl 5 mg......................................Nasal decongestant
Uses
â– temporarily relieves common cold/flu symptoms: â– nasal congestion â– sinus congestion & pressure â– cough due to minor throat & bronchial irritation â– minor aches & pains â– headache â– fever â– sore throat â– reduces swelling of nasal passages â– temporarily restores freer breathing through the nose â– promotes nasal and/or sinus drainage â– 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 â– more than 4 doses in 24 hours, which is the maximum daily amount for this product â– with other drugs containing acetaminophen â– 3 or more alcoholic drinks every day while using this product
Drug Facts (continued)
WARNINGS SECTION
Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: â– skin reddening â– bulers â– 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
â– with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist. â– 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.
Ask A Doctor Before Use If You Have
â– liver disease â– heart disease â– high blood pressure â– thyroid disease â– diabetes â– trouble urinating due to enlarged prostate gland â– cough that occurs with too much phlegm (mucus) â– persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Otc - Ask Doctor/pharmacist Section
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Otc - When Using Section
When using this product, do not use more than directed.
Drug Facts (continued)
Stop use and ask a doctor if
â– you get nervous, dizzy or sleepless â– pain, nasal congestion, or cough gets worse or lasts more than 7 days â– fever gets worse or lasts more than 3 days â– redness or swelling is present â– new symptoms occur â– cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Taking 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 as well as for children even if you do not notice any signs or symptoms.
Directions
â– take only as directed - see Overdose warning â– do not exceed 4 doses per 24 hours
 adults & children 12 years & over  2 softgels with water every 4 hours  children 4 to under 12 years  ask a doctor  children under 4 years  do not use
â– when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing
Other Information
â– store at room temperature
Inactive Ingredients
FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
NIGHTTIME COLD AND FLU
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
OTC - PURPOSE SECTION
Active ingredients (in each softgel)Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Purposes Acetaminophen 325 mg............................Pain reliever/fever reducer Dextromethorphan HBr 10 mg.............................Cough suppressant Doxylamine succinate 6.25 mg.....................................Antihistamine Phenylephrine HCl 5 mg......................................Nasal decongestant
Uses
â– temporarily relieves common cold/flu symptoms: â– nasal congestion â– sinus congestion & pressure â– cough due to minor throat & bronchial irritation â– cough to help you sleep â– minor aches & pains â– headache â– fever â– sore throat â– runny nose & sneezing â– reduces swelling of nasal passages â– temporarily restores freer breathing through the nose â– promotes nasal and/or sinus drainage
Warnings
Liver warning This product contains acetaminophen. Severe liver damage may occur if you take â– more than 4 doses in 24 hours, which is the maximum daily amount for this product â– with other drugs containing acetaminophen â– 3 or more alcoholic drinks every day while using this product
WARNINGS SECTION
Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: â– skin reddening â– bulers â– rash If a skin reaction occurs, stop use and seek medical help right away.
WARNINGS SECTION
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.
Nighttime Cold And Flu
Drug Facts (continued)
Do Not Use
â– with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist. â– 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. â– to make a child sleep
Ask A Doctor Before Use If You Have
â– liver disease â– heart disease â– high blood pressure â– thyroid disease â– diabetes â– glaucoma â– cough that occurs with too much phlegm (mucus) â– a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema â– trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
â– taking sedatives or tranquilizers â– taking the blood thinning drug warfarin
When Using This Product
â– do not use more than directed â– excitability may occur, especially in children â– marked drowsiness may occur â– avoid alcoholic drinks â– be careful when driving a motor vehicle or operating machinery â– alcohol, sedatives, and tranquilizers may increase drowsiness
Nighttime Severe Cold And Flu Softgels
Drug Facts (continued)
Stop Use And Ask A Doctor If
â– you get nervous, dizzy or sleepless â– pain, nasal congestion, or cough gets worse or lasts more than 7 days â– fever gets worse or lasts more than 3 days â– redness or swelling is present â– new symptoms occur â– cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Taking 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 as well as for children even if you do not notice any signs or symptoms.
Directions
â– take only as directed - see Overdose warning â– do not exceed 4 doses per 24 hours
 adults & children 12 years & over  2 softgels with water every 4 hours  children 4 to under 12 years  ask a doctor  children under 4 years  do not use
Other Information
store at room temperature
Inactive Ingredients
D&C Yellow #10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, shellac, sorbitol sorbitan, sodium hydroxide, titanium dioxide
Questions Or Comments?
Call toll free: 1-888-333-9792
Principal Display Panel
DAYTIME COLD AND FLU
ACETAMINOPHEN / PAIN RELIEVER DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT GUAIFENESIN / EXPECTORANT PHENYLEPHRINE HCl / NASAL DECONGESTANT
MAXIMUM STRENGTH
ACTUAL SIZE
16SOFTGELS
NIGHTTIME COLD AND FLU
ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT DOXYLAMINE SUCCINATE / ANTIHISTAMINE PHENYLEPHRINE HCl / NASAL DECONGESTANT
MAXIMUM STRENGTH
ACTUAL SIZE
8SOFTGELS
TOTAL 24 SOFTGELS
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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