GUAIFENESIN 600 MG- guaifenesin tablet, extended release

Guaifenesin 600 mg by

Drug Labeling and Warnings

Guaifenesin 600 mg by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

Principal Display Panel- 600mg Carton

Guaifenesin Extended-Release Tablets 600 mg Carton Label

INGREDIENTS AND APPEARANCE

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

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 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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215932	09/01/2022

Labeler - CVS Pharmacy (062312574)