Guaifenesin Extended-Release GUAIFENESIN PRECISION DOSE INC. FDA Approved Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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Substance Guaifenesin
Route
ORAL
Applications
ANDA078912

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each extended-release tablet) Guaifenesin 600 mg
Inactive Ingredients
Inactive ingredients Carbomer homopolymer type B FD&C blue #1 aluminum lake hypromellose magnesium stearate microcrystalline cellulose sodium starch glycolate
Strengths
600 mg
Quantities
100 tablets 0 pack
Treats Conditions
Uses Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Rid The Bronchial Passageways Of Bothersome Mucus And Make Coughs More Productive
Pill Appearance
Shape: oval Color: blue Imprint: L2X2

Identifiers & Packaging

Container Type BOX
UPC
0368094048613
UNII
495W7451VQ
Packaging

PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton PrecisionDose™ NDC 68094-048-61 Unit Dose guaiFENesin Extended-Release Tablets, 600 mg 100 Tablets (10 x 10) (in each extended-release tablet) Guaifenesin 600 mg....Expectorant. Directions: do not crush, chew, or break tablet take with a full glass of water Unique Bi-Layer Tablet GLUTEN FREE USUAL DOSE: See Enclosed Drug Facts Store at 20-25°C (68-77°F) Keep out of reach of children. Hospital Use Only. LC1384 R0 Packaged by: Precision Dose, Inc. South Beloit, IL 61080 PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton PrecisionDose™ NDC 68094-048-61 Unit Dose guaiFENesin Extended-Release Tablets, 600 mg 100 Tablets (10 x 10) (in each extended-release tablet) Guaifenesin 600 mg....Expectorant. Directions: do not crush, chew, or break tablet take with a full glass of water Unique Bi-Layer Tablet GLUTEN FREE USUAL DOSE: See Enclosed Drug Facts Store at 20-25°C (68-77°F) Keep out of reach of children. Hospital Use Only. LC1384 R0 Packaged by: Precision Dose, Inc. South Beloit, IL 61080 PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton

Overview

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Indications & Usage

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage & Administration

Directions Use as directed per healthcare professional. 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: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. children under 12 years of age: do not use

Warnings & Precautions
Warnings Do not use for children under 12 years of age 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) Stop use and ask a 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 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. (1-800-222-1222)
Purpose

Purpose Expectorant

Do Not Use

Do not use for children under 12 years of age

Stop Use & Ask a Doctor

Stop use and ask a 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.

Keep Out of Reach of Children

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)

Storage & Handling

Other information store at 20-25°C (68-77°F)

Questions

Questions or comments? 1-800-397-9228


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