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Guaifenesin - Medication Information

Product NDC Code 69848-017
Drug Name

Guaifenesin

Type Generic
Pharm Class Decreased Respiratory Secretion Viscosity [PE],
Expectorant [EPC],
Increased Respiratory Secretions [PE]
Active Ingredients
Guaifenesin 600 mg/1
Route ORAL
Dosage Form TABLET, EXTENDED RELEASE
RxCUI drug identifier 636522
Application Number ANDA213420
Labeler Name GRANULES USA, INC.
Packages
Package NDC Code Description
69848-017-02 20 tablet, extended release in 1 blister pack (69848-017-02)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients (in each extended-release bi-layer tablet) Guaifenesin 600 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 ■ do not crush, chew, or break tablet ■ take with a full glass of water ■ this product can be administered without regard for timing of meals ■ adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours ■ children under 12 years of age: do not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients carbomer homopolymer type B; hypromellos, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

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 the bronchial passageways of bothersome mucus and make coughs more productive

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.
Guaifenesin Guaifenesin GUAIFENESIN GUAIFENESIN CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) HYPROMELLOSE 2910 (5 MPA.S) SODIUM STARCH GLYCOLATE TYPE A MICROCRYSTALLINE CELLULOSE MAGNESIUM STEARATE G;600

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.
PDP 20ct

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 ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ cough accompanied by too much 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.
If pregnant or breat-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 (1-800-222-1222)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

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 doctor if ■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Storage and handling

Information about safe storage and handling of the drug product.
Other information ■ Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing. ■ store between 20-25°C (68-77°F)

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.
Do not use ■ for children under 12 years of age

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