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

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