AIR POWER - guaifenesin tablet 
Schwabe North America, Inc

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.

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AIR POWER

Guaifenesin 200 mg

INACTIVE INGREDIENTS:  carnauba wax, cellulose, dextrin, fenugreek seed extract, glycerin, hypromellose, magnesium stearate, maltodextrin, marshmallow root extract, mullein leaf extract, povidone, silica, sodium croscarmellose, stearic acid.


Dosage:  Adults and Children 12 years and over:
  1-2 tabletss every 4 hours, not to exceed 12 tablets in 24 hours.
Children 6 to 11 years of age: 1/2 to 1 tablets every 4 hours not to exceed 6 tablets in 24 hours.

Children under 6 years of age:  consult a doctor.

Purpose: Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of mucus and make coughs more productive.

Indications:

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

Warnings: Do not use this product if you are pregnant, attempting to become pregnant, or breast-feeding. 

Do not take this product for persistent or chronic cough such that occurs with smoking, asthma, chronic bronchitis or emphysema or where cough is accompaied by excessive phlegm (mucus) unless directed by a doctor.

Ask a doctor before use if you have:
Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
have a cough that is accompanied by excessive phlegm (mucus).
have diabetes
are taking antibiotics or any other prescription drug.

Stop use and ask a doctor if cough persists more than one week, tends to recur, or is accompanied by a fever, rash or persisient headache.
A persistent cough may be a sign of a serious condition.

If you are taking any medications, consult a healthcare professional before use. Keep out of reach of children. In case of overdoese seek medical help or contact a Posion Control Center immediately.

Ask a doctor before use if you have:
Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

have a cough that is accompanied by excessive phlegm (mucus).

have diabetes

are taking antibiotics or any other prescription drug. 


Stop use and ask a doctor if cough persists more than one week, tends to recur, or is accompanied by a fever, rash or persisient headache.
A persistent cough may be a sign of a serious condition.

Keep out of the reach of children.

In case of overdose, seek medical help or contact a Poison Control Center immediately.

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AIR POWER  
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59800-0232
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
FENUGREEK SEED (UNII: 654825W09Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
VERBASCUM THAPSUS LEAF (UNII: ANX0EG34JE)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorbrown (light brown to gray-brown w/ light and/or dark specks) Scoreno score
ShapeOVAL (Convex face, debossed 232 tablet) Size20mm
FlavorImprint Code 232
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59800-0232-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/19/200302/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/19/200306/29/2023
Labeler - Schwabe North America, Inc (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe North America, Inc831153908manufacture(59800-0232)

Revised: 6/2021
 
Schwabe North America, Inc