NDC 55758-313 Antigrip Nighttime

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hci

NDC Product Code 55758-313

NDC Code: 55758-313

Proprietary Name: Antigrip Nighttime Additional informationCallout TooltipWhat 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.

Non-Proprietary Name: Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hci Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 55758 - Pharmadel Llc
    • 55758-313 - Antigrip Nighttime

NDC 55758-313-18

Package Description: 18 POUCH in 1 CARTON > 1 POWDER, FOR SOLUTION in 1 POUCH

NDC Product Information

Antigrip Nighttime with NDC 55758-313 is a a human over the counter drug product labeled by Pharmadel Llc. The generic name of Antigrip Nighttime is acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hci. The product's dosage form is powder, for solution and is administered via oral form.

Labeler Name: Pharmadel Llc

Dosage Form: Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Antigrip Nighttime Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CHLORPHENIRAMINE MALEATE 4 mg/1
  • ACETAMINOPHEN 650 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • WATER (UNII: 059QF0KO0R)
  • ACESULFAME (UNII: MA3UYZ6K1H)
  • ASPARTAME (UNII: Z0H242BBR1)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SUCROSE (UNII: C151H8M554)
  • TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pharmadel Llc
Labeler Code: 55758
FDA Application Number: part341 Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-28-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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: N Additional informationCallout TooltipWhat 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Antigrip Nighttime Product Label Images

Antigrip Nighttime 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

Otc - Purpose

Active ingredients (in each packet)PurposesAcetaminophen 650 mg………………………………………………………………Pain reliever/ fever reducer Dextromethorphan HBr 20 mg……………………………………………………………Cough suppressantPhenylephrine HCI 10 mg…….………………………………..……………………………Nasal decongestantChlorpheniramine maleate 4 mg…………………………………………………………Antihistamine

Uses

  • For the temporary relief of the common cough and cold/flu symptoms:reduces feversore throatheadachemuscular achesbackachesminor aches and painsrunny nosesneezingitching of the nose or throatitchy, watery eyes due to hay fever or other upper respiratory allergiesnasal & sinus congestionstuffy nosecough due to minor throat and bronchial irritation

Warnings

  • Liver Warning: This product contains
  • Acetaminophen. Severe liver damage may occur if you take
  • More than 6 packets in 24 hours, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productAllergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:
  • Skin reddeningblistersrashIf 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 non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.for more than 10 days for pain unless directed by a doctorfor more than 3 days for fever unless directed by a doctorif you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this productto sedate a child

Ask A Doctor Before Use If You Have

  • Liver disease n heart diseasehigh blood pressurethyroid diseasediabetes n glaucomaa breathing problem such as emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate glanda persistent or chronic cough as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking the blood thinning drug warfarin

When Using This Product

  • May cause drowsiness; alcohol, sedatives and tranquilizers may increase drowsinessavoid alcoholic beveragesuse caution when driving a motor vehicle or operating machineryexcitability may occur, especially in children

Stop Use And Ask Doctor If

  • Symptoms do not improvenew symptoms occurpain or fever persists or gets worseredness or swelling is presentnervousness, dizziness, or sleeplessness occurssymptoms persists for more than 7 days, gets worse, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of an accidental 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.

Directions

  • DO NOT EXCEED RECOMMENDED DOSE take every
  • 4 hours; do not exceed 6 packets in a 24 hour period
  • Dissolve the contents of one packet into 8 oz. of hot water and sip while hot; consume entire drink within 10-15 minutesif using a microwave; add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat.AgeDoseadults and children 12 years of age and overone packet every 4 hourschildren under 12 years of agedo not use; unless directed by a doctor
  • Children under 6 years of agedo not use

Other Information

  • Each packet contains: sodium 26.73 mg, potassium 9.71 mg
  • Phenylketonurics: contains phenylalanine 13 mg per packet
  • Store at room temperature 68-77°F (20-25°C)avoid excessive heat and moistureTAMPER EVIDENT: Do not use if carton or packets are torn or punctured.

Inactive Ingredients

Acesulfame potassium, artificial flavor, aspartame, citric acid, colloidal silicon dioxide, isopropyl alcohol, maltodextrin, tribasic calcium phosphate, sodium citrate, sucrose, water

* Please review the disclaimer below.

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