GUAIFENESIN tablet, extended release

Guaifenesin by

Drug Labeling and Warnings

Guaifenesin by is a Otc medication manufactured, distributed, or labeled by BluePoint Laboratories, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

(in each extended-release tablet)

Guaifenesin USP 600 mg

Purpose

Expectorant

Uses

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

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).

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

Other information

• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised starch (maize)

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

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

INGREDIENTS AND APPEARANCE

GUAIFENESIN 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-561
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	600 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
POVIDONE K90 (UNII: RDH86HJV5Z)
POVIDONE K25 (UNII: K0KQV10C35)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	L;68
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68001-561-17	8 in 1 CARTON	03/15/2023
1	NDC: 68001-561-16	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210453	03/15/2023

Labeler - BluePoint Laboratories (985523874)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650918514	analysis(68001-561) , manufacture(68001-561)