Label: MUCUS RELIEF D- guaifenesin and pseudoephedrine hcl tablet, extended release
- NDC Code(s): 70000-0608-1
- Packager: LEADER/ Cardinal Health 110, Inc.
- This is a repackaged label.
- Source NDC Code(s): 55111-799
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 28, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
-
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
-
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)
-
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- Carton
-
INGREDIENTS AND APPEARANCE
MUCUS RELIEF D
guaifenesin and pseudoephedrine hcl tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0608(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:70000-0608-1 2 in 1 CARTON 05/16/2022 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 ANDA208369 05/16/2022 Labeler - LEADER/ Cardinal Health 110, Inc. (063997360)