Label: MUCUS RELIEF SINUS- guaifenesin and phenylephrine hcl tablet, film coated
- NDC Code(s): 63187-587-30, 63187-587-60
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0904-5792
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 1, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients (in each immediate-release tablet)
- Purpose
-
Uses
- •
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- •
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
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- 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
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- difficulty 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
- Other information
- Inactive ingredients
-
Principal Display Panel
NDC 63187-587-30
Mucus Relief
SinusGuaifenesin 400 mg /
Phenylephrine HCl 10 mgExpectorant / Nasal Decongestant
- •
- Alleviates Chest Congestion
- •
- Relieves Nasal/Sinus Congestion
- •
- Does Not Contain Pseudoephedrine
30 Tablets
Immediate
ReleaseTAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 REV0612D54201
Distributed by Major Pharmaceuticals
31778 Enterprise Drive, Livonia, MI 48150 USARelabeled by Proficient Rx LP
Thousand Oaks, CA 91320
Rev. 12/14 M-17 Re-order No. 006474 -
INGREDIENTS AND APPEARANCE
MUCUS RELIEF SINUS
guaifenesin and phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-587(NDC:0904-5792) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score no score Shape OVAL Size 16mm Flavor Imprint Code 44;542 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-587-30 1 in 1 CARTON 12/01/2015 1 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:63187-587-60 1 in 1 CARTON 12/01/2015 2 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/15/2006 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(63187-587) , RELABEL(63187-587)