FDA Label for Daytime Nighttime Cold/flu
View Indications, Usage & Precautions
Daytime Nighttime Cold/flu Product Label
The following document was submitted to the FDA by the labeler of this product Agile Pharmachem. 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 Ingredient
(in each softgel) of daytime cold and flu
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
(in each softgel) of nighttime cold and flu
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg
Purpose
Daytime Cold and Flu:
pain reliever
Cough Suppressant
Nasal decongestant
Nighttime cold and flu purpose:
pain reliever
Cough Suppressant
Antihistamine
Uses
Daytime cold and flu: pain reliever, cough suppressant and Nasal decongestant
NightTime Cold and Flu: pain reliever, cough suppressant and Antihistamine
Warnings
Warnings Failure to follow these warnings could result in serious consequences.
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours which is maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
do not use:
- with any other drug containing acetaminophen (prescription or not prescription). 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.
Ask a doctor before use if you have
- liver disease
- Heart disease
- Thyroid disease
- Diabetes
- High blood pressure
- Trouble urinating due to enlarged prostate gland
ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed.
Stop use and ask a doctor if:
- Redness or swelling is present
- You get nervous, dizzy or sleepless
- Fever gets worse or lasts more than 3 days
- New symptoms occur
- Symptoms do not get better within 7 days or are accompanied by a fever
NightTime Cold and Flu: Warnings Failure to follow these warnings could result in serious consequences.
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours which is maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
- with any other drug containing acetaminophen (prescription or not prescription). 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.
- liver disease
- Heart disease
- Thyroid disease
- Diabetes
- High blood pressure
- Trouble urinating due to enlarged prostate gland
ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed.
Stop use and ask a doctor if:
- Redness or swelling is present
- You get nervous, dizzy or sleepless
- Fever gets worse or lasts more than 3 days
- New symptoms occur
- Symptoms do not get better within 7 days or are accompanied by a fever
do not use:
Ask a doctor before use if you have
If pregnant or breast-feeding, ask a health professional before use.
Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.
Keep Out Of Reach Of Children.
If pregnant or breast-feeding, ask a health professional before use.
Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.
Direction
Daytime Cold and Flu:
- do not exceed 4 doses per 24 hours
- take only as directed – see overdose warning
- Adults and children 12 years and over: 2 softgels with water every 4 hours
- children under 12 years: ask a doctor
- Children under 4 years: do not use
NightTime Cold and Flu
- do not exceed 4 doses per 24 hours
- take only as directed – see overdose warning
- Adults and children 12 years and over: 2 softgels with water every 4 hours
- children under 12 years: ask a doctor
- Children under 4 years: do not use
Other Information
- store at controlled temperature of 59°F to 86°F(15°C to 30°C)
- Protect from direct sun light /Moisture/Freezing
Inactive Ingredients
Daytime:
FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide
NightTime:
FD&C Blue No.1, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide, glycerin
Questions Or Comments
Call toll free 1-855-314-1850
Package Label.Principal Display Panel
NDC: 58805-004-12 12 softgels, 8 DayTime Cold and Flu, 4 NightTime Cold and Flu
NDC: 58805-004-16 12 softgels, 8 DayTime Cold and Flu, 4 NightTime Cold and Flu
NDC: 58805-004-18 12 softgels, 8 DayTime Cold and Flu, 4 NightTime Cold and Flu
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