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| Product NDC Code | 43598-108 | ||||
|---|---|---|---|---|---|
| Drug Name | Guaifenesin 1200 mg |
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| Type | Brand | ||||
| Pharm Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, EXTENDED RELEASE | ||||
| Application Number | ANDA215932 | ||||
| Labeler Name | Dr. Reddy's Laboratories Inc. | ||||
| Packages |
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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 feedingIf 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