GUAIFENESIN AND PSEUDOEPHEDRINE HCL tablet, extended release
Guaifenesin and Pseudoephedrine HCL by
Drug Labeling and Warnings
Guaifenesin and Pseudoephedrine HCL by is a Otc medication manufactured, distributed, or labeled by Dr. Reddys Laboratories Limited, Dr. Reddys Laboratories Limited (SEZ UNIT). Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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Active ingredient(s)
Guaifenesin USP, 600 mg................................................................................Expectorant
Pseudoephedrine HCl USP, 60 mg......................................................Nasal Decongestant
Guaifenesin USP, 1200 mg................................................................................Expectorant
Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant
- Purpose
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Use(s)
■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive
■ temporarily relieves nasal congestion due to:
■ common cold
■ hay fever
■ upper respiratory allergies
■ temporarily restores freer breathing through the nose
■ promotes nasal and/or sinus drainage
■ 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 drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if
■ heart disease
■ high blood pressure
■ thyroid disease
■ diabetes
■ trouble urinating due to an enlarged prostate gland
■ 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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Directions
■ do not crush, chew, or break tablet
■ take with a full glass of water
■ this product can be administered without regard for timing of meals
■ children under 12 years of age: do not use
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
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
- Other information
- Storage
- Inactive ingredients
- Questions
- Principal Display Panel
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GUAIFENESIN AND PSEUDOEPHEDRINE HCL
guaifenesin and pseudoephedrine hcl tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 55111-798 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 600 mg Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride 60 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color ORANGE Score no score Shape CAPSULE Size 17mm Flavor Imprint Code RDY;798 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 55111-798-09 1 in 1 CARTON 12/29/2017 1 9 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC: 55111-798-18 2 in 1 CARTON 12/29/2017 2 9 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC: 55111-798-36 4 in 1 CARTON 12/29/2017 3 9 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC: 55111-798-35 1 in 1 CARTON 01/23/2020 4 18 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC: 55111-798-41 2 in 1 CARTON 03/11/2020 5 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 ANDA208369 12/29/2017 GUAIFENESIN AND PSEUDOEPHEDRINE HCL
guaifenesin and pseudoephedrine hcl tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 55111-799 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 1200 mg Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride 120 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color ORANGE Score no score Shape CAPSULE Size 22mm Flavor Imprint Code RDY;799 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 55111-799-12 1 in 1 CARTON 12/29/2017 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC: 55111-799-24 2 in 1 CARTON 12/29/2017 2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC: 55111-799-36 3 in 1 CARTON 12/29/2017 3 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC: 55111-799-04 4 in 1 CARTON 12/29/2017 4 NDC: 55111-799-06 6 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 ANDA208369 12/29/2017 Labeler - Dr. Reddys Laboratories Limited (650562841) Establishment Name Address ID/FEI Business Operations Dr. Reddys Laboratories Limited (SEZ UNIT) 860037244 manufacture(55111-798, 55111-799) , analysis(55111-798, 55111-799)
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