Chest Congestion

Manufacturer: Accudial Pharmaceutical, Inc.
Effective date: 2013-02-06
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:34:27

Label at a glance#

ProductChest Congestion

Active ingredientGuaifenesin

Label structure10 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Storage and handling

each teaspoon contains: sodium 3 mg store between 20°-25°C (68°-77°F) tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact877-434-2036

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin, USP 100 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the child has a cough that occurs with too much phlegm (mucus) or persistant or chronic cough such as occurs with asthma.

Directions

DOSAGE & ADMINISTRATION SECTION

may be given every 4 hours
do not use more than 6 times in 24 hours
use only enclosed dosing cup to dose this product. Do not use any other dosing device.

OTC - STOP USE SECTION

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

OTC - ASK DOCTOR/PHARMACIST SECTION

Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.

Age (yr)	Dose (TSP)
TSP = teaspoon
under 4 yrs.	ask a doctor
4 to under 6	½ TSP to 1 TSP
6 to under 12	1 TSP to 2 TSP
or as directed by a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.

Other information

STORAGE AND HANDLING SECTION

each teaspoon contains: sodium 3 mg
store between 20°-25°C (68°-77°F)
tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial flavor, citric acid, corn syrup FD&C blue #1, D&C red #33, glycerin, purified water sodium benzoate, sodium saccharin, sucralose, xanthan gum.

Questions?

OTC - QUESTIONS SECTION

877-434-2036

SPL UNCLASSIFIED SECTION

Distributed by: AccuDial® Pharmaceutical, Inc.
Palm Beach Gardens, FL 33408

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACCUDIAL_®
Children's
Chest
Congestion

Guaifenesin
Oral Solution Expectorant

Relieves Chest Congestion
Thins & Loosens Mucus

Earth-Friendly
Package!

For Ages 4 yrs to under 12 yrs

Tamper Evident

Compares to
Mucinex^® For Kids

GRAPE
FLAVOR

NDC 45014-163-04
4 FL. OZ. (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	1
310604	guaifenesin 20 MG/ML Oral Solution	SCD	1
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	1
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	1
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	1
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	1
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45014-163-04	2019-11-27	C162847	48780-1	9855d018-ea4d-cd31-e053-dbdaa90ab51a	Chest Congestion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45014-163-04	Chest Congestion	118 mL in 1 BOTTLE	SOLUTION	118		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45014-163	CHEST CONGESTION (GUAIFENESIN) SOLUTION [ACCUDIAL PHARMACEUTICAL, INC.]	1	Legacy NDC, 1 package rows	20130209_37c6ebc3-55fe-4158-a5d6-05c5b4bb5f50.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	1
Guaifenesin	ACTIVE MOIETY	495W7451VQ	1
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	1
Corn Syrup	INACTIVE INGREDIENT	9G5L16BK6N	1
D&C Red No. 33	INACTIVE INGREDIENT	9DBA0SBB0L	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
Sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Chest Congestion
Guaifenesin
Citric Acid Monohydrate
Corn Syrup
FD&C Blue No. 1
D&C Red No. 33
Glycerin
Water
Sodium Benzoate
Saccharin Sodium
Sucralose
Xanthan Gum

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
45014-163	45014-163-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Guaifenesin	495W7451VQ	ACTIB
Citric Acid Monohydrate	2968PHW8QP	IACT
Corn Syrup	9G5L16BK6N	IACT
FD&C Blue No. 1	H3R47K3TBD	IACT
D&C Red No. 33	9DBA0SBB0L	IACT
Glycerin	PDC6A3C0OX	IACT
Water	059QF0KO0R	IACT
Sodium Benzoate	OJ245FE5EU	IACT
Saccharin Sodium	SB8ZUX40TY	IACT
Sucralose	96K6UQ3ZD4	IACT
Xanthan Gum	TTV12P4NEE	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 344 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET / SUBLINGUAL		12 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	LOTION / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	GEL / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Corn Syrup	CORN SYRUP	9G5L16BK6N	TABLET / ORAL	14.07 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOAP / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, LIQUID FILLED / ORAL	0.08 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE / ORAL		3822 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / AURICULAR (OTIC)	0.04 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / IRRIGATION		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / RESPIRATORY (INHALATION)	0.13 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / ORAL		269 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM / SUBLINGUAL	0.07 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / RESPIRATORY (INHALATION)	0.03 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	GUM, CHEWING / BUCCAL		70 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	TROCHE / ORAL		60 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / VAGINAL	0.49 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / RECTAL		452 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / OPHTHALMIC	0.03 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO, SUSPENSION / TOPICAL	0.25 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
c7ba2caf-ed17-4171-b900-4d3e0155cdc4			37c6ebc3-55fe-4158-a5d6-05c5b4bb5f50	2013-02-06	Warnings	Exact identifier spl id: c7ba2caf-ed17-4171-b900-4d3e0155cdc4 spl set id: 37c6ebc3-55fe-4158-a5d6-05c5b4bb5f50

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.