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DAYTIME NIGHTTIME COLD/FLU by AGILE PHARMACHEM

Medically reviewed on Sep 20, 2017

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg, DOXYLAMINE SUCCINATE 6.25mg
Labeler: AGILE PHARMACHEM
NDC Code: 58805-004

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.

Acetaminophen, Dextromethorphan and Phenylephrine Day time Cold and Flu

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

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

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

DAYTIME NIGHTTIME COLD/FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58805-004
Packaging
#Item CodePackage Description
1NDC:58805-004-121 KIT in 1 CARTON
2NDC:58805-004-161 KIT in 1 CARTON
3NDC:58805-004-181 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK
Part 21 BLISTER PACK
Part 1 of 2
DAYTIME COLD AND FLU 
acetaminophen,dextromethorphan,phenylephrine capsule, liquid filled
Product Information
Item Code (Source)NDC:76168-055
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
POLYETHYLENE GLYCOL 1000 
POVIDONE 
PROPYLENE GLYCOL 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code512
Contains    
Packaging
#Item CodePackage Description
18 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart341
Part 2 of 2
NIGHTTIME COLD AND FLU 
acetaminophen,dextromethorphan,doxylamine capsule, liquid filled
Product Information
Item Code (Source)NDC:76168-056
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
GELATIN 
POLYETHYLENE GLYCOL 1000 
POVIDONE 
PROPYLENE GLYCOL 
SORBITOL 
TITANIUM DIOXIDE 
GLYCERIN 
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code215
Contains    
Packaging
#Item CodePackage Description
14 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart341
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/2014
Labeler - AGILE PHARMACHEM (650687853)
Registrant - VELOCITY PHARMA (962198409)
Establishment
NameAddressID/FEIOperations
medgel677385498manufacture(58805-004)

 
AGILE PHARMACHEM

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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