NDC 30142-736 Maximum Strength Nighttime Cold And Flu

Acetaminophen , Diphenhydramine Hcl, Phenylephrine Hcl

NDC Product Code 30142-736

NDC 30142-736-06

Package Description: 180 mL in 1 BOTTLE

NDC Product Information

Maximum Strength Nighttime Cold And Flu with NDC 30142-736 is a a human over the counter drug product labeled by The Kroger Co. The generic name of Maximum Strength Nighttime Cold And Flu is acetaminophen , diphenhydramine hcl, phenylephrine hcl. The product's dosage form is liquid and is administered via oral form.

Labeler Name: The Kroger Co

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What 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.

Maximum Strength Nighttime Cold And Flu Active Ingredient(s)

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

  • ACETAMINOPHEN 650 mg/20mL
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/20mL
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/20mL

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Administration Route(s)

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

Product Labeler Information

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

Labeler Name: The Kroger Co
Labeler Code: 30142
FDA Application Number: part341 What 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. What 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: 09-04-2020 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: 12-31-2021 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: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Maximum Strength Nighttime Cold And Flu Product Label Images

Maximum Strength Nighttime Cold And 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

Other

Drug Facts

Otc - Purpose

Active ingredients (in each 20 mL)PurposesAcetaminophen 650 mgPain reliever/fever reducerDiphenhydramine HCl 25 mgAntihistamine/cough suppressantPhenylephrine HCl 10 mgNasal decongestant

Uses

  • •temporarily relieves these common cold and flu symptoms: •cough •nasal congestion •minor aches and pains •sore throat •headache •runny nose •sneezing •temporarily reduces fever •controls cough to help you get to sleep

Liver Warning:

  • This product contains acetaminophen. Severe liver damage may occur if you take: •more than 6 doses in 24 hours, which is the maximum daily amount •with other drugs containing acetaminophen •3 or more alcoholic drinks daily while using this productAllergy 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. •with any other drug containing diphenhydramine, even one used on the skin •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 •high blood pressure •thyroid disease •diabetes •trouble urinating due to an enlarged prostate gland •glaucoma •a breathing problem such as emphysema or chronic bronchitis •persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysemacough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If

  • •you are taking the blood thinning drug warfarin •taking sedatives or tranquilizers

When Using This Product

  • •do not use more than directed •excitability may occur, especially in children •marked drowsiness may occur •alcohol, sedatives, and tranquilizers may increase drowsiness •avoid alcoholic drinksbe careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

  • •nervousness, dizziness, or sleeplessness occur •pain, nasal congestion, or cough gets worse or lasts more than 7 days •fever gets worse or lasts more than 3 days •redness or swelling is present •new symptoms occur •cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Directions

  • •do not take more than directed (see Overdose warning) •do not take more than 6 doses in any 24-hour period •measure only with dosing cup provided •do not use dosing cup with other products •dose as follows or as directed by a doctor •mL= milliliter •adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours •children under 12 years of age: do not use

Other Information

  • •each 20 mL contains: sodium 6 mg •low sodium •store at room temperature •do not refrigerate •dosing cup provided

Inactive Ingredients

Anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, natural and artificial flavor, potassium citrate ,propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

* Please review the disclaimer below.