NDC | 68788-0845-2, 68788-0845-3, 68788-0845-6 |
Set ID | 31257238-a0b0-4f2c-98ea-c24b8a6dc30a |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- 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
- •
- 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 you have
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- difficulty in urination due to enlargement of the prostate gland
- •
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- •
- cough accompanied by too much phlegm (mucus)
Stop use and ask a doctor if
- •
- nervousness, dizziness, or sleeplessness occur
- •
- symptoms do not improve within 7 days or are accompanied by fever
- •
- cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
-
Principal Display Panel
MAJOR®
NDC 0904-5792-46
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 REV0118E54201
Distributed by MAJOR PHARMACEUTICALS17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA
REV. 02/18 M-17 Re-order No. 006474 -
INGREDIENTS AND APPEARANCE
SINUS CONGESTION PE
guaifenesin and phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-0845(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:68788-0845-2 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/14/2014 2 NDC:68788-0845-3 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/14/2014 3 NDC:68788-0845-6 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/14/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/14/2014 Labeler - Preferred Pharmaceuticals, Inc. (791119022) Registrant - Preferred Pharmaceuticals, Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals, Inc. 791119022 REPACK(68788-0845)