Topcare Cold and Sore Throat

Manufacturer: TOPCARE (Topco Associates LLC)
Effective date: 2014-05-20
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:39:21

Label at a glance#

ProductTopcare Cold and Sore Throat Lemon Flavor

Active ingredientAcetaminophen, Pheniramine Maleate, Phenylephrine hydrochloride

Label structure7 sections

Label contents#

Full prescribing information#

Topcare 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 a 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 occurs
- 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

MM1.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	1
1796460	acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution	SCD	1
1796460	acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Granule for Oral Solution	SY	1
1796460	acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Packet for Oral Solution	SY	1
1796460	APAP 325 MG / Pheniramine Maleate 20 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution	SY	1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
36800-802-06	2020-01-31	C162847	48780-1	9d75b9d0-a8c1-f424-e053-dadaa90a57ce	Topcare Cold and Sore Throat Lemon Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-802-06	Topcare Cold and Sore ThroatLemon Flavor	6 in 1 BOX	GRANULE, FOR SOLUTION	6		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-802	TOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]	1	Legacy NDC, 1 package rows	20140521_ef12626d-dc9e-4e07-9e97-6edf0ea82f9c.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.

Topcare Cold and Sore Throat Lemon Flavor
Acetaminophen, Pheniramine Maleate, Phenylephrine HCl
Acetaminophen
Pheniramine Maleate
Pheniramine
Phenylephrine hydrochloride
Phenylephrine
Citric acid monohydrate
Ethylcellulose (100 MPA.S)
Cellulose, microcrystalline
Povidone
Silicon dioxide
Sodium citrate
Sucrose
Ascorbic acid

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
36800-802	36800-802-06

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
Acetaminophen	362O9ITL9D	ACTIB
Pheniramine Maleate	NYW905655B	ACTIB
Phenylephrine hydrochloride	04JA59TNSJ	ACTIB
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

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
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EFFERVESCENT / ORAL	460 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SUBCUTANEOUS		28 mg	Exact identifier — unii candidate 88 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	TABLET / ORAL	914 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
Cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	PELLET / ORAL		1140 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION, EXTENDED RELEASE / ORAL	140.8 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Povidone	POVIDONE	FZ989GH94E	DROPS / ORAL	NA		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
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / BUCCAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Ethylcellulose (100 MPA.S)	ETHYLCELLULOSE (100 MPA.S)	47MLB0F1MV	TABLET, EXTENDED RELEASE / ORAL		1323 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Ascorbic acid	ASCORBIC ACID	PQ6CK8PD0R	GEL / TOPICAL		7 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Ascorbic acid	ASCORBIC ACID	PQ6CK8PD0R	SOLUTION / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 25 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 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	SOLUTION / INTRAMUSCULAR	0.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM, EXTENDED RELEASE / TRANSDERMAL	1.38 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 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
Sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 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
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / IONTOPHORESIS	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	GEL / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Povidone	POVIDONE	FZ989GH94E	TABLET / SUBLINGUAL	6 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Povidone	POVIDONE	FZ989GH94E	TABLET, ORALLY DISINTEGRATING / ORAL	15.03 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Povidone	POVIDONE	FZ989GH94E	CAPSULE, COATED PELLETS / ORAL	10.03 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Povidone	POVIDONE	FZ989GH94E	TABLET, FOR SUSPENSION / ORAL	2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 88 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
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / AURICULAR (OTIC)	0.2 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Ascorbic acid	ASCORBIC ACID	PQ6CK8PD0R	INJECTION, SOLUTION / INTRAVENOUS		4 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / RECTAL		7 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAVENOUS		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INHALANT / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Povidone	POVIDONE	FZ989GH94E	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 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
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	DOUCHE / VAGINAL	0.07 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
Silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 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
Sucrose	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SUSPENSION / ORAL		840 mg	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
1a65c0d8-e9dd-4c1c-801b-b5a505a4ccc2			ef12626d-dc9e-4e07-9e97-6edf0ea82f9c	2014-05-20	Warnings	Exact identifier spl id: 1a65c0d8-e9dd-4c1c-801b-b5a505a4ccc2 spl set id: ef12626d-dc9e-4e07-9e97-6edf0ea82f9c

Reported adverse events (FAERS/openFDA)#

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