GUAIFENESIN tablet, extended release

Guaifenesin by

Drug Labeling and Warnings

Guaifenesin by is a Otc medication manufactured, distributed, or labeled by Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Active ingredient (in each extended-release tablet)

Guaifenesin 600 mg

Active ingredient (in each extended-release tablet)

Guaifenesin 1200 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.

Pregnancy/Breastfeeding

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

600 mg

• do not crush, chew, or break tablet
• take with a full glass of water
• this product can be administered without regards 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

 1200 mg

• do not crush, chew, or break tablet
• take with a full glass of water
• this product can be administered without regards for the timing of meals
• adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
• children under 12 years of age: do not use

Other information

• Tamper evident: Do not use if printed foil under cap is broken or missing.

Storage

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

Inactive ingredients

carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and talc

Questions

1-877-835-5472 You may also report side effects to this phone number.

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ  08807

Rev. 12-2017-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUAIFENESIN 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65162-036
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
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	BLUE (light blue)	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	AN036
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65162-036-02	2 in 1 CARTON	07/27/2018
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 65162-036-03	1 in 1 CARTON	07/27/2018
2		30 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 65162-036-06	1 in 1 CARTON	07/27/2018
3		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA207342	07/27/2018

GUAIFENESIN 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65162-037
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	1200 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	BLUE (light blue)	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	AN037
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65162-037-28	2 in 1 CARTON	07/27/2018
1		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 65162-037-03	1 in 1 CARTON	07/27/2018
2		30 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 65162-037-06	1 in 1 CARTON	07/27/2018
3		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA207342	07/27/2018

Labeler - Amneal Pharmaceuticals LLC (123797875)

Establishment
Name	Address	ID/FEI	Business Operations
Amneal Pharmaceuticals of New York, LLC		123797875	ANALYSIS(65162-036, 65162-037) , LABEL(65162-036, 65162-037) , MANUFACTURE(65162-036, 65162-037) , PACK(65162-036, 65162-037)