NDC 42961-112 Xpect Cold Relief

Acetaminophen Guaifenesein Phenylephrine Hcl

NDC Product Code 42961-112

NDC 42961-112-03

Package Description: 80 PACKET in 1 BOX > 2 TABLET in 1 PACKET (42961-112-01)

NDC Product Information

Xpect Cold Relief with NDC 42961-112 is a a human over the counter drug product labeled by Cintas Corporation. The generic name of Xpect Cold Relief is acetaminophen guaifenesein phenylephrine hcl. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Cintas Corporation

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Xpect Cold Relief 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.

  • GUAIFENESIN 200 mg/1
  • ACETAMINOPHEN 325 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1

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)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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.

Product Labeler Information

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

Labeler Name: Cintas Corporation
Labeler Code: 42961
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: 03-29-2021 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: 12-31-2022 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 - NO 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.

Xpect Cold Relief Product Label Images

Xpect Cold Relief 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

Purpose

Active ingredients (in each tablet)Acetaminophen 325mg……………..Internal AnalgesicGuaifenesin 200mg……………………...ExpectorantPhenylephrine HCl 5mg……………Nasal decongestant

Uses

Temporarily:• Relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies• Relieves sinus congestion and pressure, helps decongest sinus openings and passages• Restores free breathing• Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes and make coughs more productiveTemporarily relieves minor aches, pains, and fever associated with:• Headache• Common cold• Toothache• Backache• Muscular aches• Menstrual cramps

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:• More than 8 tablets in 24 hours, which is the maximum daily amount• With other drugs containing acetaminophen• 3 or more alcoholic drinks every day while using this productAllergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:• Skin reddening• Blisters• RashIf a skin reaction occurs, stop use and seek medical help right away.Do Not Use:• 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 pharmacists before using this product.• With any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.Ask doctor or pharmacist before use if you are taking the blood thinner, warfarin.When using this product do not exceed recommended dose.Stop use and ask doctor if:• Nervousness, dizziness, or sleeplessness occurs• Symptoms do not improve within 7 days or are accompanied by fever• Pain or fever persists or gets worse• New symptoms occur• Redness or swelling is present• Cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.Ask a doctor before use if you have:• Liver disease• Heart disease• High blood pressure• Thyroid disease• Difficulty in urination due to enlargement of the prostate gland• Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus)If pregnant or breast feeding, ask a health professional before use.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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Directions

• Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed. Do not exceed 8 tablets in 24 hours, or as directed by a doctor.• Children under 12 years: Consult a doctor

Other Information

• Do not use if packet is torn, cut or opened• Store at controlled room temperature 15 to 30C (59 to 86F)• Avoid excessive heat and humidity

* Please review the disclaimer below.