DailyMed - GUAIFENESIN tablet, extended release

NDC Code(s): 65162-036-02, 65162-036-03, 65162-036-06, 65162-037-03, view more
65162-037-06, 65162-037-28
Packager: Amneal Pharmaceuticals LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 7, 2024

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Active ingredient(s)
Active ingredient (in each extended-release tablet) Guaifenesin 600 mg - Active ingredient (in each extended-release tablet) Guaifenesin 1200 mg

Active ingredient (in each extended-release tablet)

Guaifenesin 600 mg

Active ingredient (in each extended-release tablet)

Guaifenesin 1200 mg
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Purpose
Expectorant

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

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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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 ...
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).

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Directions
600 mg - do not crush, chew, or break extended-release 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 ...
600 mg
- do not crush, chew, or break extended-release 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 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours.
- children under 12 years of age: do not use
1200 mg
- do not crush, chew, or break extended-release 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 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours.
- children under 12 years of age: do not use
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Other information
Tamper evident: Do not use if printed foil under cap is broken or missing.
- Tamper evident: Do not use if printed foil under cap is broken or missing.
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Storage
store between 20° to 25°C (68° to 77°F)
- store between 20° to 25°C (68° to 77°F)
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Inactive ingredients
carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and talc

carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and talc
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Questions
1-877-835-5472 You may also report side effects to this phone number. Distributed by: Amneal Pharmaceuticals LLC - Bridgewater, NJ 08807 - Rev. 10-2024-01

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

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 10-2024-01
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
...

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INGREDIENTS AND APPEARANCE

Product Information

GUAIFENESIN guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65162-036
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207342	07/27/2018

Labeler - Amneal Pharmaceuticals LLC (123797875)

Name	Address	ID/FEI	Business Operations
Establishment
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)

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Published Date (What is this?)	Version	Files
Oct 28, 2024	12 (current)	download
Dec 19, 2023	11	download
Dec 26, 2022	10	download
Dec 29, 2020	9	download
Dec 30, 2019	8	download
Aug 1, 2018	7	download
Jul 26, 2018	6	download

	RxCUI	RxNorm NAME	RxTTY
1	310621	guaiFENesin 1200 MG 12HR Extended Release Oral Tablet	PSN
2	310621	12 HR guaifenesin 1200 MG Extended Release Oral Tablet	SCD
3	310621	guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY
4	636522	guaiFENesin 600 MG 12HR Extended Release Oral Tablet	PSN
5	636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD
6	636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY

Label: GUAIFENESIN tablet, extended release

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Pregnancy/Breastfeeding

Keep out of reach of children

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	65162-036-02
2	65162-036-03
3	65162-036-06
4	65162-037-03
5	65162-037-06
6	65162-037-28

Label: GUAIFENESIN tablet, extended release

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Pregnancy/Breastfeeding

Keep out of reach of children

Find additional resources

Safety

Related Resources

More Info on this Drug

GUAIFENESIN tablet, extended release

Number of versions: 7

GUAIFENESIN tablet, extended release

GUAIFENESIN tablet, extended release

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GUAIFENESIN tablet, extended release

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.