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Guaifenesin 1200 mg - Medication Information

Product NDC Code 43598-108
Drug Name

Guaifenesin 1200 mg

Type Brand
Pharm Class Decreased Respiratory Secretion Viscosity [PE],
Expectorant [EPC],
Increased Respiratory Secretions [PE]
Active Ingredients
Guaifenesin 1200 mg/1
Route ORAL
Dosage Form TABLET, EXTENDED RELEASE
RxCUI drug identifier 310621,
636522
Application Number ANDA215932
Labeler Name Dr. Reddy's Laboratories Inc.
Packages
Package NDC Code Description
43598-108-37 3 blister pack in 1 carton (43598-108-37) / 14 tablet, extended release in 1 blister pack
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient(s) Guaifenesin 600 mg (for 600mg) Guaifenesin 1200 mg (for 1200 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 the timing of meals adults and children 12 years of age and over: 1or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours (for 600 mg) adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours (for 1200 mg) 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, colloidal silicon dioxide, ferric oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate type A

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.
Use(s) helps loosen phlegum (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 600 mg Guaifenesin Guaifenesin Guaifenesin Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) Silicon Dioxide Ferric Oxide Red Hydroxypropyl Cellulose (110000 Wamw) Hypromellose 2910 (10000 Mpa.S) Hypromellose 2208 (4000 Mpa.S) Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Potato 6 White on debossed side and Light Pink to Pink on other side Guaifenesin 1200 mg Guaifenesin Guaifenesin Guaifenesin Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) Silicon Dioxide Ferric Oxide Red Hydroxypropyl Cellulose (110000 Wamw) Hypromellose 2910 (10000 Mpa.S) Hypromellose 2208 (4000 Mpa.S) Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Potato White on debossed side and Light Pink to Pink on other side 12 600mgCarton 1200mgcarton

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- 600mg Carton Guaifenesin Extended-Release Tablets 600 mg Carton Label Principal Display Panel - 1200 mg Carton Guaifenesin Extended-Release Tablets 1200 mg Carton 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.
Other information store at 20-25°C (68-77°F) Distributed by: Dr. Reddy’s Laboratories, Inc. Princeton, NJ 08540 Made in India I 0721

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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus)

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.
Do not use For children under 12 years age

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 aPoison 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? call 1-888-375-3784 Weekdays (9am - 8pm EST) You may also report side effects to this phone number.

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.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If Pregnancy/Breastfeeding, 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 Applicable warning(s) in 201.66(c)(5)(i) and (ii) Do not use For children under 12 years age Ask a doctor before use if persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) 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. If Pregnancy/Breastfeeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact aPoison Control Center right away (1-800-222-1222).

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