Label: AIR POWER- guaifenesin tablet
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- NDC Code(s): 59800-0232-1
- Packager: Schwabe North America, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated June 14, 2021
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
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.
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WARNINGS
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.
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ASK DOCTOR
Ask a doctor before use if you have:
Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysemahave 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 REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AIR POWER
guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59800-0232 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength 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 Color brown (light brown to gray-brown w/ light and/or dark specks) Score no score Shape OVAL (Convex face, debossed 232 tablet) Size 20mm Flavor Imprint Code 232 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59800-0232-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/19/2003 02/28/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/19/2003 06/29/2023 Labeler - Schwabe North America, Inc (831153908) Establishment Name Address ID/FEI Business Operations Schwabe North America, Inc 831153908 manufacture(59800-0232)
