NDC 52642-016 Sf Menthol Cough Drop

NDC Product Code 52642-016

NDC CODE: 52642-016

Proprietary Name: Sf Menthol Cough Drop 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):
BLUE (C48333 - LIGHT BLUE WITH BLUE FLAKES)
Shape: OVAL (C48345)
Size(s):
17 MM
Imprint(s):
B
Flavor(s):
MENTHOL (C73403)

NDC Code Structure

  • 52642 - Bestco Inc.

NDC 52642-016-00

Package Description: 200 LOZENGE in 1 BAG

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

NDC Product Information

Sf Menthol Cough Drop with NDC 52642-016 is a product labeled by Bestco Inc.. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 476973.

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.

  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

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

Labeler Name: Bestco Inc.
Labeler Code: 52642
Start Marketing Date: 06-30-2015 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: 12-31-2019 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.

Sf Menthol Cough Drop 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 drop)Menthol 5.8 mg

Otc - Purpose

PurposeCough suppressant/Oral anesthetic

Indications & Usage

Uses temporarily relieves:cough as may occur wiht a coldoccasional minor irritation and sore throat

Warnings

WarningsSore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.

Otc - Ask Doctor

Ask a doctor before use if you have:persistent or chronic cough such as occurs with smoking, asthma, or emphysemacough accompanied by excessive phlegm (mucus)

Otc - When Using

When using this productdo not exceed recommended dosage

Otc - Stop Use

Stop use and consult doctor ifcough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.sore throat is severe, or irritation, pain or redness lasts or worsenssore mouth does not improve in 7 days

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children.

Overdosage

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

Dosage & Administration

Directions adults and children 5 years and over allow 1 drop to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.children under 5 years ask a doctor.

Other Safety Information

Other information6 calories per dropExcess conlsumption may cause a laxative effect.

Inactive Ingredient

Inactive ingredients: Acesulfame potassium, blue flakes (FD&C blue #1, glycerin, gum arabic, potassium sorbate), eucalyptus oil, FD&C Blue #1, FD&C Red #40, hydrogenated starch hydrolysate, isomalt, N&A flavoring, sucralose, & water. Soybean oil and corn starch used as processing aids.

Otc - Questions

Questions? Or to report an adverse event call 1-800-245-2898. Monday through Friday, 9AM to 4PM EST

* Please review the disclaimer below.