Select Brand Mucus Relief DailyMed Label

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active ingredient - (per tablet) Guaifenesin 400 mg Phenylephrine HCl 10 mg

Purpose

Guaifenesin.......................Expectorant Phenylephrine HCl..............Nasal decongestant

Uses

Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies. ■ helps loosen phlegm (mucus) ■ clear nasal passageways ■ loosens nasal congestion ■ drain bronchial tubes ■ shrinks swollen membranes ■ clears stuffy nose ■ makes coughs more productive

Warnings

Do not exceed recommended dosage

Do not use

■ this product 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.

Ask a doctor before use if you have

■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ excessive phlegm;mucus ■ difficulty in urination due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema

Stop use and ask a doctor if

■ nervousness, dizziness or sleeplessness occurs ■ symptoms are accompanied by fever, rash, persistent headache or excessive phlegm (mucus) ■ cough and congestion do not improve within 7 days or tend to recur. These could be signs of a serious condition .

Directions And Dosage

Directions

■ adults and children 12 years and over: take 1 caplet every 4 hours as needed ■ children 6 to under 12 years: take 1/2 caplet every 4 hours as needed ■ children under 6 years: consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor.

Other Label Information

Inactive ingredients

lactose, magnesium silicate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, titanium dioxide and triacetin

Label Images#

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1304111	guaiFENesin 400 MG / phenylephrine HCl 10 MG Oral Tablet	PSN	1
1304111	guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
15127-171-50	2020-01-31	C162847	48780-1	9d75b9d0-cb02-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
15127-171-50	Select Brand Mucus Relief PE	1 in 1 CARTON	TABLET	1		1
15127-171-50	Select Brand Mucus Relief PE	50 in 1 BOTTLE	TABLET	50		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15127-171	SELECT BRAND MUCUS RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [SELECT BRAND DISTRIBUTORS]	1	Legacy NDC, 2 package rows	20140926_ab7ca98a-e6ca-4f91-a199-e69b9c86b4e2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
15127-171-50	EA - Each	15127-171	7d73582d-a08e-4e08-bc6b-437b10752d5b	1	2017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	1
Guaifenesin	ACTIVE MOIETY	495W7451VQ	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	1
MAGNESIUM SILICATE	INACTIVE INGREDIENT	9B9691B2N9	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	1

Products#

Select Brand Mucus Relief PE
Guaifenesin/phenylephrine
PHENYLEPHRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
15127-171	15127-171-50

Ingredients#

Name, UNII, Kind table
Name	UNII	Kind
Guaifenesin	495W7451VQ	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
LACTOSE	J2B2A4N98G	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
MINERAL OIL	T5L8T28FGP	IACT
POVIDONE	FZ989GH94E	IACT
MAGNESIUM SILICATE	9B9691B2N9	IACT
MAGNESIUM STEARATE	70097M6I30	IACT

Complete SPL Sections#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient - (per tablet) Guaifenesin 400 mg Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Guaifenesin.......................Expectorant Phenylephrine HCl..............Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies. ■ helps loosen phlegm (mucus) ■ clear nasal passageways ■ loosens nasal congestion ■ drain bronchial tubes ■ shrinks swollen membranes ■ clears stuffy nose ■ makes coughs more productive

Warnings

WARNINGS SECTION

Do not exceed recommended dosage

Do not use

OTC - DO NOT USE SECTION

■ this product 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ excessive phlegm;mucus ■ difficulty in urination due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ nervousness, dizziness or sleeplessness occurs ■ symptoms are accompanied by fever, rash, persistent headache or excessive phlegm (mucus) ■ cough and congestion do not improve within 7 days or tend to recur. These could be signs of a serious condition .

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding , ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

■ adults and children 12 years and over: take 1 caplet every 4 hours as needed ■ children 6 to under 12 years: take 1/2 caplet every 4 hours as needed ■ children under 6 years: consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

lactose, magnesium silicate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, titanium dioxide and triacetin

Source Document#

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