GUAIFENESIN EXTENDED-RELEASE- guaifenesin tablet, multilayer, extended release 
Precision Dose Inc.

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Guaifenesin Extended-Release

Drug Facts

Active ingredient (in each extended-release tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

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.

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

Other information

Inactive ingredients

Carbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

1-800-397-9228

Gluten Free

How Supplied

NDC 68094-048-61
Unit Dose Packages of 100 Tablets (10×10) per Carton

Distributed by:
Perrigo
Allegan, MI 49010

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

LI1382 Rev. 06/22

PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton

PrecisionDose™

NDC 68094-048-61
Unit Dose

guaiFENesin
Extended-Release
Tablets,

600 mg

100 Tablets
(10 x 10)

(in each extended-release tablet)
Guaifenesin 600 mg....Expectorant.

Directions: do not crush, chew, or
break tablet take with a full glass of water

Unique Bi-Layer Tablet
GLUTEN FREE

USUAL DOSE: See Enclosed Drug Facts
Store at 20-25°C (68-77°F)

Keep out of reach of children.
Hospital Use Only.

LC1384
R0

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton
GUAIFENESIN EXTENDED-RELEASE 
guaifenesin tablet, multilayer, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-048(NDC:0113-2023)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin600 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize16mm
FlavorImprint Code L2X2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68094-048-6110 in 1 CARTON03/22/2023
1NDC:68094-048-5910 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07891203/22/2023
Labeler - Precision Dose Inc. (035886746)

Revised: 11/2023
Document Id: 1361c408-4dfb-47f9-8f81-37eb00b70b2f
Set id: 608b00c5-a2c7-4514-9b46-02954d6675d6
Version: 2
Effective Time: 20231115
 
Precision Dose Inc.