Your browser does not support JavaScript! MUCUS RELIEF (GUAIFENESIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]
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RxNorm Names

MUCUS RELIEF (guaifenesin) tablet
[P and L Development of New York Corporation (ReadyInCase)]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active ingredient (in each tablet)

Guaifenesin 400 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

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 condition.

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

  • adults and children 12 years of age and older:
    •  take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 tablets in 24 hours.
  • children under 12 years of age: do not use 

Other information

  • each tablet contains: sodium 5 mg
  • store at 20-25ºC (68-77ºF)

Inactive ingredients

colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Immediate Acting Mucus Relief

Guaifenesin 400 mg

Expectorant

  • Relieves Chest Congestion
  • Thins and Loosens Mucus

Tablets

Distributed by: PL Developments

200 Hicks Street

Westbury, NY 11590

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Guaifenesin 400 mg

ReadyInCase Mucus Relief Tablet

MUCUS RELIEF 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59726-107
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONES 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize13mm
FlavorImprint Code TCL272;G1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-107-151 in 1 BOX
115 in 1 BOTTLE, PLASTIC
2NDC:59726-107-301 in 1 BOX
230 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/07/2012
Labeler - P and L Development of New York Corporation (ReadyInCase) (800014821)

Revised: 10/2013
 
P and L Development of New York Corporation (ReadyInCase)

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