GUAIFENESIN EXTENDED-RELEASE- guaifenesin tablet, extended release 
Guardian Pharmaceuticals, LLC.

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Guaifenesin Extended-Release Tablets, 600 mg and 1200 mg

Active ingredient (in each extended-release tablet)

Guaifenesin 600 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.

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

  • 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: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
  • children under 12 years of age: do not use

Other information

  • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
  • store between 20 to 25 °C (68 to 77 °F)

Inactive ingredients

carbomer homopolymer; hypromellose; microcrystalline cellulose; povidone

Questions?

1-609-642-6816

Hours: 8am - 4pm, EST

You may also report side effects to this phone number.

Dist. by: Guardian Pharmaceuticals 2 Charles Ct, Dayton NJ 08810 USA

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.

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

  • 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: 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 carton is open or if printed seal on blister is broken or missing
  • store between 20 to 25 °C (68 to 77 °F)

Inactive ingredients

carbomer homopolymer; hypromellose; microcrystalline cellulose; povidone

Questions?

1-609-642-6816

Hours: 8am - 4pm, EST

You may also report side effects to this phone number.

Dist. by: Guardian Pharmaceuticals
2 Charles Ct, Dayton, NJ 08810 USA

PDP 600 mg

Guaifenesin

Extended-Release Tablets

600 mg

EXPECTORANT

12 Hour

Relieves Chest Congestion

Thins and Loosens Mucus

20 Extended-Release Tablets

  Guaifenesin Extended-Release Tablets 600 mg EXPECTORANT 12 Hour Relieves Chest Congestion Thins and Loosens Mucus 20 Extended-Release Tablets

PDP 1200 mg

Guaifenesin

Extended-Release Tablets

1200 mg

EXPECTORANT

12 Hour

Relieves Chest Congestion

Thins and Loosens Mucus

30 Extended-Release Tablets

Guaifenesin Extended-Release Tablets 1200 mg EXPECTORANT 12 Hour Relieves Chest Congestion Thins and Loosens Mucus 30 Extended-Release Tablets
GUAIFENESIN EXTENDED-RELEASE 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70391-233
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code G233
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70391-233-202 in 1 CARTON09/18/2017
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:70391-233-404 in 1 CARTON09/18/2017
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20921509/06/201708/14/2018
GUAIFENESIN EXTENDED-RELEASE 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70391-234
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code G234
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70391-234-303 in 1 CARTON09/18/2017
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:70391-234-404 in 1 CARTON09/18/2017
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20921509/06/201708/14/2018
Labeler - Guardian Pharmaceuticals, LLC. (080059401)
Registrant - Guardian Drug Company (119210276)

Revised: 10/2017
Document Id: 5ace6f16-3839-02c7-e053-2991aa0acdd8
Set id: c257a7d4-c245-4b66-a075-7890c6fec02a
Version: 6
Effective Time: 20171005
 
Guardian Pharmaceuticals, LLC.