Quality Choice Cold and Sore Throat

Manufacturer: Chain Drug Marketing Association
Effective date: 2016-01-07
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:44:35

Label at a glance#

ProductQuality Choice Cold and Sore Throat Lemon Flavor

Active ingredientACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE

Label structure7 sections

Label contents#

Full prescribing information#

Quality Choice Cold and Sore Throat Lemon Flavor

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each packet) Purpose

Acetaminophen 325 mg...................................Pain reliever/Fever reducer

Pheniramine maleate 20 mg................................................Antihistamine

Phenylephrine hydrochloride 10 mg.............................Nasal decongestant.

OTC - PURPOSE SECTION

Uses

- temporarily relieves these symptoms due to a cold:

- minor aches and pains - headache - minor sore throat pain

- nasal congestion - temporarily reduces fever

- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

- runny nose - sneezing - itchy nose and throat - itchy, watery eyes.

WARNINGS SECTION

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets in 24 hours, which is the maximum daily amount - with other drugs containing acetaminophen - 3 or more alcoholic drinks every day while using this product.

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

OTC - DO NOT USE SECTION

Do not use - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

- 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.

- with any other product containing acetaminophen (see Overdose Warning).

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

- liver disease - heart disease - high blood pressure - thyroid disease - diabetes - glaucoma - a breathing problem such as emphysema, asthma, or chronic bronchitis - trouble urinating due to an enlarged prostate gland - a sodium-restricted diet.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking

- sedatives or tranquilizers - the blood thinning drug warfarin.

INDICATIONS & USAGE SECTION

When using this product

- do not exceed recommended dosage

- avoid alcoholic drinks - may cause drowsiness

- alcohol, sedatives, and tranquilizers may increase drowsiness

- be careful when driving a motor vehicle or operating machinery

- excitability may occur, especially in children.

OTC - STOP USE SECTION

Stop use and ask a doctor if

- nervousness, dizziness, or sleeplessness occur

- pain or nasal congestion gets worse or lasts more than 7 days

- fever gets worse or lasts more than 3 days

- redness or swelling is present

- new symptoms occur

- sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

Overdose Warning: Taking more than the recommended dose can cause serious health problems, including serious liver damage. In case of overdose, get medical help or contact a poison control center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

- do not use more than directed (see Overdose Warning)

- take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor

- adults and children 12 years of age and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.

- children under 12 years of age: consult a doctor

- If using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

INFORMATION FOR PATIENTS SECTION

Other Information

- each packet contains: sodium 66 mg

- store at controlled room temperature 20-25C (68-77F).

INACTIVE INGREDIENT SECTION

Citric acid, D and C Yellow 10, Ethylcellulose, FD and C Red 40, Flavor, Microcrystalline cellulose, Povidone, Silicon Dioxide, Sodium Citrate, Starch, Sugar and Vitamin C.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton1.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1796460	acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine HCl 10 MG Powder for Oral Solution	PSN	2
1796460	acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution	SCD	2
1796460	acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Granule for Oral Solution	SY	2
1796460	acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Packet for Oral Solution	SY	2
1796460	APAP 325 MG / Pheniramine Maleate 20 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
63868-765-06	2020-01-31	C162847	48780-1	9d75b9d0-2794-f424-e053-dadaa90a57ce	Quality Choice Cold and Sore Throat Lemon Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-765-06	Quality Choice Cold and Sore ThroatLemon Flavor	6 in 1 BOX	GRANULE, FOR SOLUTION	6		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-765	QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]	2	Legacy NDC, 1 package rows	20160108_7047e4b8-d111-4540-89e0-5f29dc17a03d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	1
Pheniramine Maleate	ACTIVE INGREDIENT	NYW905655B	1
Phenylephrine hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	1
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	1
Pheniramine	ACTIVE MOIETY	134FM9ZZ6M	1
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	1
Ascorbic acid	INACTIVE INGREDIENT	PQ6CK8PD0R	1
Cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	1
Citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	1
Ethylcellulose (100 MPA.S)	INACTIVE INGREDIENT	47MLB0F1MV	1
Povidone	INACTIVE INGREDIENT	FZ989GH94E	1
Silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
Sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Quality Choice Cold and Sore Throat Lemon Flavor
Acetaminophen, Pheniramine Maleate, Phenylephrine HCl
CITRIC ACID MONOHYDRATE
ETHYLCELLULOSE (100 MPA.S)
CELLULOSE, MICROCRYSTALLINE
POVIDONE
SILICON DIOXIDE
SODIUM CITRATE
SUCROSE
ASCORBIC ACID
ACETAMINOPHEN
PHENIRAMINE MALEATE
PHENIRAMINE
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63868-765	63868-765-06

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
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
ETHYLCELLULOSE (100 MPA.S)	47MLB0F1MV	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POVIDONE	FZ989GH94E	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SUCROSE	C151H8M554	IACT
ASCORBIC ACID	PQ6CK8PD0R	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB
PHENIRAMINE MALEATE	NYW905655B	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB

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 5 · 271 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, DELAYED RELEASE / ORAL	789.6 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE / ORAL		238 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Ascorbic acid	ASCORBIC ACID	PQ6CK8PD0R	CAPSULE, DELAYED RELEASE / ORAL		12 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Ascorbic acid	ASCORBIC ACID	PQ6CK8PD0R	SOLUTION / RESPIRATORY (INHALATION)	0.04 %w/w		Exact identifier — unii candidate 25 equally ranked IID candidates
Ascorbic acid	ASCORBIC ACID	PQ6CK8PD0R	SUPPOSITORY / RECTAL	3 mg		Exact identifier — unii candidate 25 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Povidone	POVIDONE	FZ989GH94E	SYSTEM / TOPICAL		41 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Povidone	POVIDONE	FZ989GH94E	CAPSULE, EXTENDED RELEASE / ORAL		56 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION, CONCENTRATE / INTRAVENOUS	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
Cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY, METERED / NASAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION/ DROPS / ORAL		19 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY / NASAL		9 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Povidone	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Povidone	POVIDONE	FZ989GH94E	SOLUTION / ORAL		3000 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / EPIDURAL	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Ethylcellulose (100 MPA.S)	ETHYLCELLULOSE (100 MPA.S)	47MLB0F1MV	CAPSULE, EXTENDED RELEASE / ORAL		880 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Ascorbic acid	ASCORBIC ACID	PQ6CK8PD0R	GEL / TOPICAL		7 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Ascorbic acid	ASCORBIC ACID	PQ6CK8PD0R	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 25 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO / TOPICAL		17 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
Ascorbic acid	ASCORBIC ACID	PQ6CK8PD0R	TABLET, ORALLY DISINTEGRATING / ORAL	2.35 mg		Exact identifier — unii candidate 25 equally ranked IID candidates
Ascorbic acid	ASCORBIC ACID	PQ6CK8PD0R	TABLET / ORAL		80 mg	Exact identifier — unii candidate 25 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
Sucrose	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Povidone	POVIDONE	FZ989GH94E	TROCHE / ORAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EFFERVESCENT / ORAL	460 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 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	POWDER, FOR SOLUTION / ORAL		315 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Povidone	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / TOPICAL	0.01 %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
28c4fcc2-0a53-1752-e054-00144ff8d46c			7047e4b8-d111-4540-89e0-5f29dc17a03d	2016-01-07	Warnings	Exact identifier spl id: 28c4fcc2-0a53-1752-e054-00144ff8d46c spl set id: 7047e4b8-d111-4540-89e0-5f29dc17a03d

Reported adverse events (FAERS/openFDA)#

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