topcare day time cold and flu relief

Manufacturer: Topco Associates LLC
Effective date: 2026-02-16
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-06-01 01:47:13

Label at a glance#

Producttopcare day time cold and flu relief multi symptom relief

Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

• temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • nasal congestion • minor aches and pains • sore throat • headache • fever

Dosage and administration

• take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use

Storage and handling

• each 15 mL contains: sodium 15 mg • store at 20-25 ° C (68-77 ° F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-423-0139

Label contents#

Full prescribing information#

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:
cough due to minor throat and bronchial irritation
nasal congestion
minor aches and pains
sore throat
headache
fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

adult takes more than 4,000 mg of acetaminophen in 24 hours
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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.
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

you get nervous, dizzy or sleepless
pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

take only as directed – see Overdose warning
only use the dose cup provided
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	30 mL every 4 hrs
children 6 to under 12 yrs	15 mL every 4 hrs
children 4 to under 6 yrs	ask a doctor
children under 4 yrs	do not use

Other information

STORAGE AND HANDLING SECTION

each 15 mL contains: sodium 15 mg
store at 20-25^°C (68-77^°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C yellow no. 6, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare_®health

COMPARE TO VICKS^® DAYQUIL^® ACTIVE INGREDIENTS

MULTI-SYMPTOM RELIEF

Day Time Cold & Flu Relief

PAIN RELIEVER – FEVER REDUCER – ACETAMINOPHEN

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

NASAL DECONGESTANT – PHENYLEPHRINE HCl

• Headache, Fever, Sore Throat, Minor Aches & Pains

• Nasal Congestion

• Cough

Alcohol Free

Antihistamine Free

Non-Drowsy

12 FL OZ (355 mL)

ORIGINAL FLAVOR

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1113705	Acetaminophen/Dextromethorphan/Phenylephrine (Oral Liquid)	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	12
1113705	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	12
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	12
1113705	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	12
1113705	APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SY	12

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
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
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
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
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	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
36800-522-34	2026-01-29	C162847	48780-1	49896155-c463-586f-e063-e6dba90add90	Topco Associates LLC. Day Time Cold & Flu Relief Drug Facts
36800-522-38	2026-01-29	C162847	48780-1	49896155-c463-586f-e063-e6dba90add90	Topco Associates LLC. Day Time Cold & Flu Relief Drug Facts
36800-522-40	2026-01-29	C162847	48780-1	49896155-c463-586f-e063-e6dba90add90	Topco Associates LLC. Day Time Cold & Flu Relief Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
36800-522-34	topcare day time cold and flu reliefmulti symptom relief	237 mL in 1 BOTTLE	SOLUTION	237	12
36800-522-38	topcare day time cold and flu reliefmulti symptom relief	296 mL in 1 BOTTLE	SOLUTION	296	12
36800-522-40	topcare day time cold and flu reliefmulti symptom relief	355 mL in 1 BOTTLE	SOLUTION	355	12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	4
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	4
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	4
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	4
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	4
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	4
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	4
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	4
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	4
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	4

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

topcare day time cold and flu relief multi symptom relief
acetaminophen, dextromethorphan Hbr, Phenylephrine HCl
ACETAMINOPHEN
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
ANHYDROUS CITRIC ACID
FD&C YELLOW NO. 6
GLYCERIN
MENTHOL, UNSPECIFIED FORM
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SODIUM BENZOATE
SODIUM CHLORIDE
SODIUM CITRATE, UNSPECIFIED FORM
SORBITOL SOLUTION
SUCRALOSE
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
36800-522	36800-522-40, 36800-522-34, 36800-522-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GLYCERIN	PDC6A3C0OX	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM CITRATE, UNSPECIFIED FORM	1Q73Q2JULR	IACT
SORBITOL SOLUTION	8KW3E207O2	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 1 · 40 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SUCROSE	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	SOLUTION / ORAL		5 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SOLUTION / ORAL	25 mg/5ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SOLUTION / ORAL	25 mg/5ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	SOLUTION / ORAL		5 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / ORAL	75.3 mg/15ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SOLUTION / ORAL	25 mg/5ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SOLUTION / ORAL	25 mg/5ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	SOLUTION / ORAL		5 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / ORAL	75.3 mg/15ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / ORAL	75.3 mg/15ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / ORAL	75.3 mg/15ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	SOLUTION / ORAL		5 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii+route+dosage form 4 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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TopCare Day Time Nite Time Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates LLC	c00ff684-acaf-4fbe-bc74-7e48751b927d	2026-05-26	Warnings	Exact identifier ndc (package): 36800-522-40 ndc11 (package): 36800052240
topcare day time cold and flu relief multi symptom relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Topco Associates LLC	6d08ca2d-6ae4-443f-9920-34b7fb46f2b4	2026-02-16	Warnings	Exact identifier ndc (package): 36800-522-34 ndc (package): 36800-522-40 ndc (package): 36800-522-38 ndc (product): 36800-522 ndc11 (package): 36800052238 ndc11 (package): 36800052234 ndc11 (package): 36800052240 spl id: df6a549c-a593-42bb-9695-07a32df43c4c spl set id: 6d08ca2d-6ae4-443f-9920-34b7fb46f2b4

Reported adverse events (FAERS/openFDA)#

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