Label: GUAIFENESIN AND PSEUDOEPHEDRINE HCL tablet, extended release
- NDC Code(s): 51660-057-12, 51660-058-18
- Packager: Ohm Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 1, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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Uses
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- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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- temporarily relieves nasal congestion due to:
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- common cold
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- hay fever
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- upper respiratory allergies
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- temporarily restores freer breathing through the nose
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- promotes nasal and/or sinus drainage
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- temporarily relieves sinus congestion and pressure
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Warnings
Do not use 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 contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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- cough accompanied by too much phlegm (mucus)
When using this product
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- do not use more than directed
Stop use and ask a doctor if
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- you get nervous, dizzy, or sleepless
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- symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.
If pregnant or breast-feeding, ask a health professional before use.
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Directions
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- do not crush, chew, or break tablet
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- take with a full glass of water
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- this product can be administered without regard for timing of meals
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- For 600 mg/60 mg: adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours
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- For 1200 mg/120 mg: adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
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- children under 12 years of age: do not use
- Inactive Ingredients
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Questions?
call 1-800-406-7984
You may also report side effects to this phone number.
Keep the carton. It contains important information.
See end panel for expiration date.
†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.
Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 089010219
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Guaifenesin 600 mg and Pseudoephedrine HCl 60 mg Extended-Release Bi-Layer Tablets - Carton Label
NDC 51660-058-18
†Compare To
the active ingredients of
Mucinex® Dohm®
Guaifenesin 600 mg & Pseudoephedrine HCl 60 mg
Extended-Release Bi-Layer TabletsExpectorant & Nasal Decongestant
12 Hour
- •
- Clears Nasal/Sinus Congestion
- •
- Thins and Loosens Mucus
- •
- Immediate and Extended Release
18 Extended-Release Bi-Layer Tablets
†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.
-
Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mg Extended-Release Bi-Layer Tablets - Carton Label
NDC 51660-057-12
†Compare To
the active ingredients of
Mucinex® Dohm®
Maximum Strength
Guaifenesin 1200 mg & Pseudoephedrine HCl 120 mg
Extended-Release Bi-Layer TabletsExpectorant & Nasal Decongestant
12 Hour
- •
- Clears Nasal/Sinus Congestion
- •
- Thins and Loosens Mucus
- •
- Immediate and Extended Release
12 Extended-Release Bi-Layer Tablets
†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.
-
INGREDIENTS AND APPEARANCE
GUAIFENESIN AND PSEUDOEPHEDRINE HCL
guaifenesin and pseudoephedrine hcl tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-058 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 600 mg PSEUDOEPHEDRINE (UNII: 7CUC9DDI9F) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE 60 mg Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color WHITE (white to off-white) , ORANGE (orange to light orange) Score no score Shape OVAL Size 17mm Flavor Imprint Code 058 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51660-058-18 1 in 1 CARTON 04/01/2021 1 18 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 ANDA212542 04/01/2021 GUAIFENESIN AND PSEUDOEPHEDRINE HCL
guaifenesin and pseudoephedrine hcl tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-057 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 1200 mg PSEUDOEPHEDRINE (UNII: 7CUC9DDI9F) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE 120 mg Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color WHITE (white to off-white) , ORANGE (orange to light orange) Score no score Shape OVAL Size 22mm Flavor Imprint Code 057 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51660-057-12 1 in 1 CARTON 04/01/2021 1 12 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 ANDA212542 04/01/2021 Labeler - Ohm Laboratories, Inc. (184769029) Establishment Name Address ID/FEI Business Operations Ohm Laboratories, Inc. 184769029 MANUFACTURE(51660-058, 51660-057)
