Guaifenesin AC

Manufacturer: Rising Pharmaceuticals | Bio-Pharm, Inc.
Effective date: 2017-12-14
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:05:45

Label at a glance#

ProductGuaifenesin AC

Active ingredientGuaifenesin, Codeine Phosphate

Label structure12 sections

Dosage and administration

Take every 4 hours or as directed by a doctor. Do not exceed 6 doses in 24 hours. Adults and children 12 years of age and over: Take 2 teaspoons. Children 6 to under 12 years of age: Give 1 teaspoon. Children under 6 years of age: DO NOT USE. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Storage and handling

Dispense in a tight, light-resistant container as defined in the USP. Store at controlled room temperature 20 o - 25 o C (68 o - 77 o F). (see USP Controlled Room Temperature) DO NOT REFRIGERATE.

Contacts and useful links#

PhoneLabel contact(866) 562-4597

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Each teaspoon (5 mL) Contains:
Guaifenesin USP	100 mg
Codeine Phosphate USP	10 mg

contains 3.5% alcohol v/v

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Alcohol 3.5%, artificial cherry flavor, caramel, citric acid, disodium edetate, FD&C Red #40, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol solution.

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Temporarily relieves cough due to minor throat and bronchial irritation, as may occur with the common cold or inhaled irritants. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Take every 4 hours or as directed by a doctor. Do not exceed 6 doses in 24 hours. Adults and children 12 years of age and over: Take 2 teaspoons. Children 6 to under 12 years of age: Give 1 teaspoon. Children under 6 years of age: DO NOT USE. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

WARNINGS

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not exceed recommended dosage. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a doctor. May cause or aggravate constipation. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Do not use in children following a tonsillectomy and/or adenoidectomy as this could cause severe respiratory distress.

DRUG INTERACTION PRECAUTION

SPL UNCLASSIFIED SECTION

Caution should be used when taking this product with sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.

TO REPORT ADVERSE DRUG EVENTS CALL: (866) 562-4597

STORAGE AND HANDLING SECTION

Dispense in a tight, light-resistant container as defined in the USP.

Store at controlled room temperature 20^o - 25^o C (68^o - 77^oF). (see USP Controlled Room Temperature) DO NOT REFRIGERATE.

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Each 5 mL contains: sodium 4 mg

TAMPER-EVIDENT

SPL UNCLASSIFIED SECTION

Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing.

SPL UNCLASSIFIED SECTION

BULK CONTAINER - NOT FOR HOUSEHOLD USE.

REV 2/15

SPL UNCLASSIFIED SECTION

Manufactured by:
Bio-Pharm, Incorporated Levittown, PA 19057

Distributed by:
Rising Pharmaceuticals, Inc. Allendale, NJ 07401

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rising^® NDC 16571-302-16

Guaifenesin AC
Cough Syrup

SUGAR-FREE

GUAIFENESIN AND CODEINE
PHOSPHATE ORAL SOLUTION, USP)
COUGH SUPPRESSANT
EXPECTORANT

Each teaspoon (5 mL) Contains:Guaifenesin USP....... 100 mg
Codeine Phosphate USP..... 10 mg

contains 3.5% alcohol v/v

*Under Federal law Guaifenesin AC is available
without a prescription. Certain State laws may differ.

Manufactured by:
Bio-Pharm, Incorporated Levittown, PA 19057

Distributed by:
Rising Pharmaceuticals, Inc. Allendale, NJ 07401

TAMPER-EVIDENT
DO NOT REFRIGERATE

ONE PINT (473 mL)

LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16571-302-16	2024-02-29	C162847	48780-1	9d75b9d0-6f9d-f424-e053-dadaa90a57ce	Guaifenesin AC
16571-302-16	2020-01-31	C162847	48780-1	9d75b9d0-6f9d-f424-e053-dadaa90a57ce	Guaifenesin AC

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-302-16	ML - Milliliter	16571-302	d1e35b36-20c1-41d1-8dc9-62a0752ecb50	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Codeine Phosphate	ACTIVE INGREDIENT	GSL05Y1MN6	1
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	1
Codeine	ACTIVE MOIETY	Q830PW7520	1
Guaifenesin	ACTIVE MOIETY	495W7451VQ	1
Alcohol	INACTIVE INGREDIENT	3K9958V90M	1
Caramel	INACTIVE INGREDIENT	T9D99G2B1R	1
Cherry	INACTIVE INGREDIENT	BUC5I9595W	1
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	1
FD&C Red no. 40	INACTIVE INGREDIENT	WZB9127XOA	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Guaifenesin AC
Guaifenesin and Codeine Phosphate
Guaifenesin
Codeine Phosphate
Codeine Anhydrous
Alcohol
Cherry
Caramel
Citric Acid Monohydrate
Edetate Disodium
FD&C Red no. 40
Glycerin
Water
Saccharin Sodium
Sodium Benzoate
Sorbitol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
16571-302	16571-302-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Guaifenesin	495W7451VQ	ACTIB
Codeine Phosphate	GSL05Y1MN6	ACTIB
Alcohol	3K9958V90M	IACT
Cherry	BUC5I9595W	IACT
Caramel	T9D99G2B1R	IACT
Citric Acid Monohydrate	2968PHW8QP	IACT
Edetate Disodium	7FLD91C86K	IACT
FD&C Red no. 40	WZB9127XOA	IACT
Glycerin	PDC6A3C0OX	IACT
Water	059QF0KO0R	IACT
Saccharin Sodium	SB8ZUX40TY	IACT
Sodium Benzoate	OJ245FE5EU	IACT
Sorbitol	506T60A25R	IACT

Source Document#

Source XML · Source PDF

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 8 · 451 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	POWDER, FOR SUSPENSION / ORAL		285 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM / SUBLINGUAL		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / ORAL		315 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	GEL / RECTAL		406 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	CONCENTRATE / ORAL	5.3 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / RESPIRATORY (INHALATION)		8 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SUSPENSION / RECTAL	46.18 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	PASTE / ORAL		28 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C Red no. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
FD&C Red no. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii candidate 28 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
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 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
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SUSPENSION / ORAL		160 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INFILTRATION	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Caramel	CARAMEL	T9D99G2B1R	CREAM / TOPICAL	0.26 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / IONTOPHORESIS	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, EFFERVESCENT / ORAL		32 mg	Exact identifier — unii candidate 77 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	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / INTRAVENOUS		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAVENOUS		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C Red no. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, EXTENDED RELEASE / ORAL	2.22 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAVENOUS		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / SUBLINGUAL		24 mg	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
10e61385-f6be-40b5-8ecf-2f9f6ded7ff2			e4a455ae-07bd-43aa-b607-7179dcda7ded	2024-02-29	Warnings	Exact identifier spl set id: e4a455ae-07bd-43aa-b607-7179dcda7ded

Reported adverse events (FAERS/openFDA)#

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