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Diabetic tussin expectorant - Medication Information

Product NDC Code 61787-514
Drug Name

Diabetic tussin expectorant

Type Brand
Pharm Class Decreased Respiratory Secretion Viscosity [PE],
Expectorant [EPC],
Increased Respiratory Secretions [PE]
Active Ingredients
Guaifenesin 200 mg/10ml
Route ORAL
Dosage Form LIQUID
RxCUI drug identifier 310604,
992212
Application Number part341
Labeler Name MEDTECH PRODUCTS INC
Packages
Package NDC Code Description
61787-514-04 1 bottle in 1 box (61787-514-04) / 118 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each 10 mL) Guaifenesin 200 mg

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.
Directions take every 4 hours do not exceed 6 doses in 24 hours Adults 10 mL - 20 mL (2 - 4 teaspoons) Children under 12 years ask a doctor
Adults10 mL - 20 mL (2 - 4 teaspoons)
Children under 12 yearsask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Acesulfame K, artificial cherry flavor, artificial vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

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.
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus

Purpose

Information about the drug product’s indications for use.
Purpose Expectorant

Spl product data elements

Usually a list of ingredients in a drug product.
Diabetic Tussin Expectorant Guaifenesin GUAIFENESIN GUAIFENESIN ACESULFAME POTASSIUM ASPARTAME CHERRY HYPROMELLOSE, UNSPECIFIED MENTHOL, UNSPECIFIED FORM METHYLPARABEN POTASSIUM SORBATE VANILLA WATER ANHYDROUS CITRIC ACID artificial cherry flavor artificial vanilla flavor

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.
Principal Display Panel SUGAR & ALCOHOL FREE! Specifically Formulated for Diabetics Diabetic Tussin ® CHEST CONGESTION Guaifenesin (Expectorant) Thins & Loosens Mucus 4 FL OZ (118 mL) Diagram Description automatically generated

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.
DIABETIC TUSSIN EXPECTORANT- guaifenesin liquid Medtech Products Inc., a Prestige Consumer Healthcare company Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Drug Facts

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have: a cough that occurs with too much phlegm (mucus) a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information Phenylketonurics : contains phenylalanine 8.4 mg per teaspoonful (5 mL) store at room temperature 20-25°C (68-77°F). keep tightly closed.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Call 1-800-579-8327 , serious side effects associated with use of this product may be reported to this number. Rev #0514:00 04/19

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.
Stop use and ask a doctor if: cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts These could be signs of a serious condition.

Pregnancy or breast feeding

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

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.
Warnings Ask a doctor before use if you have: a cough that occurs with too much phlegm (mucus) a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if: cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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