MUCUS RELIEF SINUS- guaifenesin and phenylephrine hcl tablet, film coated
Major Pharmaceuticals

----------

Major 44-542-Delisted

Active ingredients (in each immediate-release tablet)

Guaifenesin 400 mg
Phenylephrine HCl 10 mg

Purpose

Expectorant
Nasal decongestant

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

thyroid disease
diabetes
high blood pressure
heart disease
cough accompanied by too much phlegm (mucus)
difficulty in urination due to enlargement of the prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product

do not exceed recommended dosage.

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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

take with a full glass of water
adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
children under 12 years: do not use

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

(800) 616-2471

Principal Display Panel

MAJOR®

NDC 0904-5792-46

Mucus Relief
Sinus

Guaifenesin 400 mg/
Phenylephrine HCl 10 mg

Expectorant / Nasal Decongestant

Alleviates Chest Congestion
Relieves Nasal/Sinus Congestion
Does Not Contain Pseudoephedrine

30 Tablets

Immediate Release

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844 REV0118E54201
Distributed by MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA
Rev. 02/18 M-17 Re-order No. 006474
Major 44-542

Major 44-542

MUCUS RELIEF SINUS
guaifenesin and phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-5792
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-5792-46	1 in 1 CARTON	04/15/2006	03/27/2024
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:0904-5792-52	1 in 1 CARTON	04/15/2006	03/27/2024
2		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	04/15/2006	03/27/2024

Labeler - Major Pharmaceuticals (191427277)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(0904-5792)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(0904-5792)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(0904-5792)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(0904-5792)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(0904-5792)

Revised: 3/2024

Document Id: 5a891e18-6d4e-43d5-bd96-66e923d5a6d5

Set id: 7f8f58a7-803b-4d62-bd8b-f05ab559a45f

Version: 13

Effective Time: 20240327

Major Pharmaceuticals