Guaifenesin GUAIFENESIN BLUEPOINT LABORATORIES FDA Approved Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

GUAIFENESIN

Generic: GUAIFENESIN
Mfr: BLUEPOINT LABORATORIES FDA OTC
FunFoxMeds box
Substance Guaifenesin
Route
ORAL
Applications
ANDA210453
Product NDC
68001-0561-00 68001-0561-16 68001-0561-17
Package NDC
68001-561-16 68001-561-17

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each extended-release tablet) Guaifenesin USP 600 mg
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide hypromellose magnesium stearate microcrystalline cellulose povidone and pregelatinised starch (maize)
Strengths
600 mg
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: white Imprint: L;68

Identifiers & Packaging

Container Type BOX
NDC 68001-0561-00
All Product Codes
68001-0561-00 68001-0561-16 68001-0561-17
UNII
495W7451VQ
SPL Set IDs
ee8a2a97-16aa-0f3e-e053-2a95a90a523b
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg Blister Foil and 600 mg Carton (80 Extended-Release Tablets, 1x10's). Blister Pack : NDC 68001-561-16 Carton Pack : NDC 68001-561-17 Guaifenesin Extended-Release Tablets 600 mg EXPECTORANT 12 HOUR Relieves Chest Congestion Thins And Loosens Mucus 80 Extended-Release Tablets Blister pack Carton

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg Blister Foil and 600 mg Carton (80 Extended-Release Tablets, 1x10's). Blister Pack : NDC 68001-561-16 Carton Pack : NDC 68001-561-17 Guaifenesin Extended-Release Tablets 600 mg EXPECTORANT 12 HOUR Relieves Chest Congestion Thins And Loosens Mucus 80 Extended-Release Tablets 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 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
Purpose

Purpose Expectorant

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 between 20° to 25°C (68° to 77°F)

Questions

Questions? 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number. Manufactured by: APL Healthcare Limited Unit-IV. Tirupati (Dt) - 524421, India For BluePoint Laboratories Made in India Code: AP/DRUGS/04/2016 Rev: 10/2022

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Additional Information

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