NDC 58805-004 Daytime Nighttime Cold/flu

NDC Product Code 58805-004

NDC CODE: 58805-004

Proprietary Name: Daytime Nighttime Cold/flu What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Product Characteristics

Color(s):
ORANGE (C48331)
GREEN (C48329)
Shape: CAPSULE (C48336)
Size(s):
22 MM
Imprint(s):
512
215
Score: 1

NDC Code Structure

NDC 58805-004-12

Package Description: 1 KIT in 1 CARTON * 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC 58805-004-16

Package Description: 1 KIT in 1 CARTON * 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC 58805-004-18

Package Description: 1 KIT in 1 CARTON * 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Daytime Nighttime Cold/flu with NDC 58805-004 is a product labeled by Agile Pharmachem. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1086997, 1094549 and 1730191.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • GLYCERIN (UNII: PDC6A3C0OX)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Agile Pharmachem
Labeler Code: 58805
Start Marketing Date: 08-01-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)
Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]
Doxylamine

Doxylamine is pronounced as (dox il' a meen)
Why is doxylamine medication prescribed?
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and ot...
[Read More]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]

* Please review the disclaimer below.

Daytime Nighttime Cold/flu Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

(in each softgel) of daytime cold and flu Acetaminophen 325 mgDextromethorphan HBr 10 mgPhenylephrine HCl 5 mg(in each softgel) of nighttime cold and flu Acetaminophen 325 mgDextromethorphan HBr 15 mgDoxylamine Succinate 6.25 mg

Purpose

Daytime Cold and Flu:pain relieverCough SuppressantNasal decongestantNighttime cold and flu purpose:pain relieverCough SuppressantAntihistamine

Uses

Daytime cold and flu: pain reliever, cough suppressant and Nasal decongestantNightTime 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 productwith other drugs containing acetaminophen3 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 haveliver diseaseHeart diseaseThyroid diseaseDiabetesHigh blood pressureTrouble 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 presentYou get nervous, dizzy or sleeplessFever gets worse or lasts more than 3 daysNew symptoms occurSymptoms 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 productwith other drugs containing acetaminophen3 or more alcoholic drinks daily while using this productdo 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 haveliver diseaseHeart diseaseThyroid diseaseDiabetesHigh blood pressureTrouble urinating due to enlarged prostate glandask 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 presentYou get nervous, dizzy or sleeplessFever gets worse or lasts more than 3 daysNew symptoms occurSymptoms do not get better within 7 days or are accompanied by a feverIf 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 hourstake only as directed – see overdose warningAdults 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 Fludo not exceed 4 doses per 24 hourstake only as directed – see overdose warningAdults 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 dioxideNightTime:FD&C Blue No.1, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide, glycerin

* Please review the disclaimer below.