NDC 69842-288 Cvs Motion Sickness Strips

Meclizine Hydrochloride

NDC Product Code 69842-288

NDC 69842-288-01

Package Description: 8 PACKET in 1 CARTON > 1 FILM, SOLUBLE in 1 PACKET

NDC Product Information

Cvs Motion Sickness Strips with NDC 69842-288 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Cvs Motion Sickness Strips is meclizine hydrochloride. The product's dosage form is film, soluble and is administered via oral form.

Labeler Name: Cvs Pharmacy

Dosage Form: Film, Soluble - A thin layer or coating which is susceptible to being dissolved when in contact with a liquid.

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.

Cvs Motion Sickness Strips 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.

  • MECLIZINE HYDROCHLORIDE 25 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.

  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • MANNITOL (UNII: 3OWL53L36A)
  • LEVOMENTHOL (UNII: BZ1R15MTK7)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SUCROSE STEARATE/PALMITATE ESTER (75% MONO ESTER) (UNII: L98X941W2B)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

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: Cvs Pharmacy
Labeler Code: 69842
FDA Application Number: part336 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: 02-20-2019 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: 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.

Cvs Motion Sickness Strips Product Label Images

Cvs Motion Sickness Strips 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 - Active Ingredient

Active ingredient (in each strip)    Meclizine hydrochloride 25mg

Otc - Purpose

PurposeMeclizine hydrochloride    Antiemetic

Indications & Usage

Uses■ For the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.

Warnings

Warnings

Otc - Do Not Use

Do not use in children under 12 years of age unless directed by a physician

Otc - Ask Doctor

Ask a physician before use if you have■ glaucoma   ■ a breathing problem such as emphysema or chronic bronchitis■ difficulty in urination due to enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist

Ask a physician or pharmacist before use if you are■ taking sedatives or tranquilizers

Otc - When Using

When using this product■ you may get drowsy   ■ avoid alcoholic beverages■ be careful when driving a motor vehicle or operating machinery■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect

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.  In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

DirectionsTo prevent motion sickness take it at least one hour before traveling    Adults and children 12 years of age and over:  Oral dosage is 1 to 2 strips (25 to 50 mg) to dissolve on tongue once daily, or as directed by a physician.

Other Safety Information

Other information■ Store tightly closed, protected from light, at 20-30°C. (68-86°F)

Inactive Ingredient

Inactive ingredientsacesulfame potassium, ferric oxide, hypromelloses, mannitol, menthol, orange oil, polyethylene glycol 400, sucralose, sucrose esters of fatty acids

* Please review the disclaimer below.

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