Active ingredient(s)

Guaifenesin 600 mg

Purpose

Expectorant

Use(s)

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

Warnings

Applicable warning(s) in 201.66(c)(5)(i) and (ii)

Do not use

For children under 12 years age

Ask a doctor before use if

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 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 Pregnancy/Breastfeeding,

ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact aPoison 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: 1or 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

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B, colloidal silicon dioxide, ferric oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate type A

Questions?

call 1-888-375-3784 Weekdays (9am - 8pm EST)

You may also report side effects to this phone number.

Principal Display Panel- 600mg Carton

Guaifenesin Extended-Release Tablets 600 mg Carton Label

carton

GUAIFENESIN 600 MG
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51316-008(NDC:43598-008)
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 Homopolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: HHT01ZNK31)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Ferric Oxide Red (UNII: 1K09F3G675)
Hydroxypropyl Cellulose (110000 Wamw) (UNII: 5Y0974F5PW)
Hypromellose 2910 (10000 Mpa.S) (UNII: 0HO1H52958)
Hypromellose 2208 (4000 Mpa.S) (UNII: 39J80LT57T)
Magnesium Stearate (UNII: 70097M6I30)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)

Product Characteristics
Color	PINK (White on debossed side and Light Pink to Pink on other side )	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	6
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51316-008-01	5 in 1 CARTON	05/01/2023
1		20 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215932	09/01/2022

Labeler - CVS Pharmacy (062312574)

Drug Facts