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Cough drops - Medication Information

Product NDC Code 84236-101
Drug Name

Cough drops

Type Brand
Active Ingredients
Menthol 5.4 mg/1
Route SUBLINGUAL
Dosage Form TABLET, ORALLY DISINTEGRATING
RxCUI drug identifier 485287
Application Number M012
Labeler Name Xiamen Misero Biotechnology Co, Ltd
Packages
Package NDC Code Description
84236-101-01 25 tablet, orally disintegrating in 1 bag (84236-101-01)
84236-101-02 30 tablet, orally disintegrating in 1 bag (84236-101-02)
84236-101-03 70 tablet, orally disintegrating in 1 bag (84236-101-03)
84236-101-04 80 tablet, orally disintegrating in 1 bag (84236-101-04)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
MENTHOL 0.18%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed. children under 5 years: ask a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
EUCALYPTUS OIL FD&C BLUE NO. 1 FD&C RED NO. 40 POTASSIUM CITRATE SOY LECITHIN SUCRALOSE SUCROSE GLUCOSE SYRUP CITRIC ACID Water

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
temporarily relieves: cough due to cold occasiona! minor irritation or sore throat

Purpose

Information about the drug product’s indications for use.
cough suppressant, oral anesthetic

Spl product data elements

Usually a list of ingredients in a drug product.
Cough Drops MENTHOL MENTHOL MENTHOL SUCRALOSE CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 SUCROSE CORN SYRUP SOYBEAN LECITHIN POTASSIUM CITRATE EUCALYPTUS OIL FD&C RED NO. 40 WATER

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
label

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Cough Drops

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Ask a doctor before use if you have: persistent or chronic cough such as occurs with smoking, asthma, or emphysema. cough accompanied by excessive phlegm (mucus).

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
cough persists for more than 1 week, tends to recur,or is accompained by tever, rash, or persistent headache. These could be sions of a serious condition. sore mouth does not improve in 7 days. irritation, pain, or redness persists or worsens.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
Ask a doctor before use if you have: persistent or chronic cough such as occurs with smoking, asthma, or emphysema. cough accompanied by excessive phlegm (mucus).

Storage and handling

Information about safe storage and handling of the drug product.
Store in a cool place.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Sore throat warninq: lf sore throat is severe, persists for more than 2 days, isaccompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctorpromptly. These may be serious.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API