Label: GUAIFENESIN AND DEXTROMETHORPHAN HBR tablet, extended release
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NDC Code(s):
58602-715-05,
58602-715-06,
58602-715-09,
58602-715-10, view more58602-715-15, 58602-715-57, 58602-715-60, 58602-715-64, 58602-715-65, 58602-715-68, 58602-715-69, 58602-715-70
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 3, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purposes
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Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
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Warnings
Do not use- for children under 12 years of age
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- Ask a doctor before use if you have
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
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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 timing of meals
- adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours
- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions?
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Bottle)
NDC 58602-715-05
MAXIMUM STRENGTH
Mucus Relief DM
Dextromethorphan HBr and Guaifenesin
Extended-release Tablets 60 mg/1200 mg
Dextromethorphan HBr 60 mg - Cough Suppressant
Guaifenesin 1200 mg - Expectorant
RELIEVES COUGH & CHEST CONGESTION
12
HOUR
√ Controls Cough
√ Thins & Loosens Mucus
14 Extended-release Tablets
AUROHEALTH
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label)
Compare to the active ingredients of
Maximum Strength Mucinex® DM*
NDC 58602-715-05
MAXIMUM STRENGTH
Mucus Relief DM
Dextromethorphan HBr
and Guaifenesin Extended-release Tablets
60 mg/1200 mg
Dextromethorphan HBr 60 mg - Cough Suppressant
Guaifenesin 1200 mg - Expectorant
RELIEVES COUGH & CHEST CONGESTION
12
HOUR
√ Controls Cough
√ Thins and Loosens Mucus
ACTUAL SIZE
14 Extended-release Tablets
AUROHEALTH
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Blister Carton 28 (4 x 7) Unit-dose Tablets
Compare to the active ingredients of
Maximum Strength Mucinex® DM*
NDC 58602-715-70
MAXIMUM STRENGTH
Mucus Relief DM
Dextromethorphan HBr and Guaifenesin
Extended-release Tablets
60 mg/1200 mg
Dextromethorphan HBr 60 mg - Cough Suppressant
Guaifenesin 1200 mg - Expectorant
RELIEVES COUGH & CHEST CONGESTION
12
HOUR
√ Controls Cough
√ Thins & Loosens Mucus
ACTUAL SIZE
28 (4 x7) Extended-release Tablets
AUROHEALTH
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INGREDIENTS AND APPEARANCE
GUAIFENESIN AND DEXTROMETHORPHAN HBR
guaifenesin and dextromethorphan hbr tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-715 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 1200 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 60 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE K90 (UNII: RDH86HJV5Z) POVIDONE K25 (UNII: K0KQV10C35) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL Size 22mm Flavor Imprint Code X;63 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-715-05 1 in 1 CARTON 03/17/2017 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:58602-715-57 1 in 1 CARTON 03/17/2017 2 28 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:58602-715-09 1 in 1 CARTON 03/17/2017 3 30 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:58602-715-68 1 in 1 CARTON 03/17/2017 4 38 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:58602-715-60 1 in 1 CARTON 03/17/2017 5 42 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:58602-715-69 1 in 1 CARTON 03/17/2017 6 44 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:58602-715-15 1 in 1 CARTON 03/17/2017 7 60 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:58602-715-70 4 in 1 CARTON 03/17/2017 8 7 in 1 BLISTER PACK; Type 0: Not a Combination Product 9 NDC:58602-715-06 6 in 1 CARTON 03/17/2017 9 7 in 1 BLISTER PACK; Type 0: Not a Combination Product 10 NDC:58602-715-65 2 in 1 CARTON 03/17/2017 10 7 in 1 BLISTER PACK; Type 0: Not a Combination Product 11 NDC:58602-715-10 6 in 1 CARTON 03/17/2017 11 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 12 NDC:58602-715-64 1 in 1 CARTON 03/17/2017 12 7 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 ANDA206941 03/17/2017 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(58602-715) , MANUFACTURE(58602-715)