MAXIMUM STRENGTH MUCUS RELIEF - guaifenesin tablet, extended release 
Bryant Ranch Prepack

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Maximum Strength Mucus Relief 

ACTIVE INGREDIENT(in each extended-release tablet)

Guaifenesin 1200 mg

PURPOSE

Expectorant

USE(S)

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

WARNING

.

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 INGREDIENT SECTION

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

QUESTIONS?

1-609-860-2600

Hours: 8am - 4pm, EST

You may also report side effects to this phone number. 

HOW SUPPLIED

Product: 63629-8348

NDC: 63629-8348-1 28 TABLET, EXTENDED RELEASE in a BOTTLE

NDC: 63629-8348-2 180 TABLET, EXTENDED RELEASE in a BOTTLE

Guaifenesin ER 1200mg Tablet

Label Image
MAXIMUM STRENGTH MUCUS RELIEF 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-8348(NDC:69230-315)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code G234
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63629-8348-128 in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
2NDC:63629-8348-2180 in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20921511/06/2019
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-8348) , RELABEL(63629-8348)

Revised: 9/2020
 
Bryant Ranch Prepack