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Select Brand Mucus Relief

Dosage form: tablet
Ingredients: Guaifenesin 200mg
Labeler: Select Brand Distributors
NDC Code: 15127-129

Disclaimer: 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 Facts

Active ingredient (per tablet)

Guaifenesin  200mg

Purpose

Expectorant

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

Warnings

Ask doctor before use if you have

  • persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema
  • cough is accompanied by excessive phlegm (mucus)

Stop use and ask doctor if

  • Symptoms are accompanied by fever, rash or persistent headache
  • cough persists for more than 1 week or tends to recur
A persistent cough may be a sign 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 immediately.

Directions
  • Adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours as needed
  • Children 6 to 10 under 12 years of age: take 1/2 to 1 tablet every 4 hours as needed
  • Children under 6 years of age: consult a doctor    
Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Other Information

store at 15°-30°C (59°-86°F)

Inactive ingredients

FD C red No. 40 (Al-lake), magnesium stearate,  maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid.

SELECT BRAND MUCUS RELIEF 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-129
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin200 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN 
STEARIC ACID 
SILICON DIOXIDE 
POVIDONE 
MAGNESIUM STEARATE 
FD&C RED NO. 40 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
Colorred (rose) Score2 pieces
ShapeROUNDSize10mm
FlavorImprint Code151
Contains    
Packaging
#Item CodePackage Description
1NDC:15127-129-601 TABLET (BOTTLE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/26/2014
Labeler - Select Brand Distributors (043562370)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIOperations
Reese Pharmaceutical Co004172052relabel(15127-129), repack(15127-129)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical Inc078301063manufacture(15127-129)

Revised: 09/2014
 
Select Brand Distributors

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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