DAYTIME NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl
Strive Pharmaceuticals Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Active ingredients (in each Softgel) (Daytime) | Purpose |
Acetaminophen 325mg | Pain Reliever/fever reducer |
Dextromethorphan HBr 10mg | Cough suppressant |
Phenylephrine HCl 5mg | Nasal Decongestant |
Active ingredients (in each Softgel) (Nighttime) | Purpose |
Acetaminophen 325mg | Pain Reliever/fever reducer |
Dextromethorphan HBr 15mg | Cough suppressant |
Docylamine Succinate 6.25mg | Antihistamine |
Daytime
Pain reliever/fever reducer, Cough suppresant and Nasal decongestant
Nighttime
Pain reliever/fever reducer, Cough suppressant and Antihistamine
* temporarily relieves common cold/flu symptoms:
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
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.
* 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 (Daytime only)
* high blood pressure (Daytime only)
* thyroid disease (Daytime only)
* trouble urinating due to an enlarged prostate gland
* glaucoma (Nighttime only)
* persistent or chronic cough such as occurs with smoking, asthma or emphysema and (Nighttime only) chronic bronchitis
* cough that occurs with too much phlegm (mucus)
Ask a doctor or a pharmacist before use if you are
* taking the blood thinning drug warfarin
* taking sedatives or tranquilizers (Nighttime only)
When using this product
Do not use more than directed. In addition when using Nighttime:
* excitability may occur, especially in children
* marked drowsiness may occur
* alcohol, sedatives, and tranquilizers may increase drowsiness
* be careful when driving a motor vehicle or operating machinery
* avoid alcoholic drinks
Stop use and ask a doctor if
* you get nervous, dizzy, or sleepless (Daytime only)
* pain, cough and nasal congestion (Daytime only) may get worse or lasts more than 7 days
* new symptoms occur
* fever gets worse or lasts more than 3 days
* redness or swelling is present
* 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 care professional before use.
Keep out of reach of children
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.
Keep out of reach of children
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.
Directions
* take only as directed - see OVERDOSE WARNING
* do not exceed 4 doses per 24 hrs
* take softgels with water
Read each label carefully before taking Daytime and Nighttime product
Daytime | Nighttime | |
adulta & children age 12 years & over | 2 softgels every 4 hours | 2 softgels every 6 hours |
children 4 to under 12 years | ask a doctor | ask a doctor |
children under 4 years | do not use | do not use |
Other information
* store at room temperature between 20 - 25°C (68 - 77°F)
*avoid excessive heat, cold and humidity
Inactive ingredients (Daytime)
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.
Inactive ingredients (Nightime)
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.
DAYTIME NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit |
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Labeler - Strive Pharmaceuticals Inc. (080028013) |