Label: MUCUS RELIEF- guaifenesin tablet, extended release
- NDC Code(s): 41226-723-02
- Packager: KROGER COMPANY
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 21, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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)
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DOSAGE & ADMINISTRATION
Directions
- do not crush, chew, or break extended-release 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 or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours.
- children under 12 years of age: do not use
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MUCUS RELIEF
guaifenesin tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41226-723 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 600 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) COPOVIDONE K25-31 (UNII: D9C330MD8B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white (Blue and White) Score no score Shape OVAL Size 16mm Flavor Imprint Code 42 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41226-723-02 1 in 1 CARTON 05/21/2024 1 20 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA217780 05/21/2024 Labeler - KROGER COMPANY (006999528) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(41226-723)