DailyMed - TOPCARE DAY TIME COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

NDC Code(s): 36800-603-34, 36800-603-40
Packager: Topco Associates LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated October 28, 2024

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Active ingredients (in each 15 mL)
Acetaminophen 325 mg - Dextromethorphan HBr 10 mg - Guaifenesin 200 mg - Phenylephrine HCl 5 mg

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg
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Purpose
Pain reliever/fever reducer - Cough suppressant - Expectorant - Nasal decongestant

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant
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Uses
temporarily relieves common cold/flu symptoms: • sore throat - • nasal congestion - • sinus congestion and pressure - • cough due to minor throat and bronchial irritation - • minor aches and ...

temporarily relieves common cold/flu symptoms:

•

sore throat

•

nasal congestion

•

sinus congestion and pressure

•

cough due to minor throat and bronchial irritation

•

minor aches and pains

•

fever

•

headache

•

reduces swelling of nasal passages

•

temporarily restores freer breathing through the nose

•

promotes nasal and/or sinus drainage

•

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

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Warnings
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 ...

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

•

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

•

liver disease

•

heart disease

•

diabetes

•

thyroid disease

•

high blood pressure

•

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, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

Stop use and ask a doctor if

•

pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)

•

you get nervous, dizzy or sleepless

•

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,

ask a health professional before use.

Keep out of reach of children.

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.

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Directions
• 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 ...

•

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

•

each 15 mL contains: sodium 6 mg

•

store at 20-25°C (68-77°F). Do not refrigerate.

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Inactive ingredients
butylated hydroxyanisole, edetate disodium, FD&C yellow #6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose ...

butylated hydroxyanisole, edetate disodium, FD&C yellow #6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions?

1-888-423-0139

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Package/Label Principal Display Panel
TopCare® health - COMPARE TO VICKS® DAYQUIL® SEVERE ACTIVE INGREDIENTS - MAXIMUM STRENGTH RELIEF - Day Time Cold & Flu - SEVERE - PAIN RELIEVER – FEVER REDUCER – ACETAMINOPHEN - COUGH SUPPRESSANT ...

TopCare® health

COMPARE TO VICKS® DAYQUIL® SEVERE ACTIVE INGREDIENTS

MAXIMUM STRENGTH RELIEF

Day Time Cold & Flu

SEVERE

PAIN RELIEVER – FEVER REDUCER – ACETAMINOPHEN

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

EXPECTORANT – GUAIFENESIN

NASAL DECONGESTANT – PHENYLEPHRINE HCl

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

• Nasal/Sinus Congestion & Sinus Pressure

• Cough

• Chest Congestion

Alcohol Free

Antihistamine Free

Non-Drowsy

12 FL OZ (355 mL)

ORIGINAL FLAVOR

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INGREDIENTS AND APPEARANCE

Product Information

TOPCARE DAY TIME COLD AND FLU acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-603
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg in 15 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg in 15 mL

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	ORANGE (clear)	Score
Shape		Size
Flavor	FRUIT, MENTHOL	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-603-34	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/22/2014	02/28/2022
2	NDC:36800-603-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/13/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	06/13/2014

Labeler - Topco Associates LLC (006935977)

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Published Date (What is this?)	Version	Files
Oct 30, 2024	9 (current)	download
Sep 19, 2022	8	download
Nov 17, 2021	7	download
Feb 11, 2020	6	download
Jan 8, 2019	5	download
Feb 23, 2018	4	download
Jun 14, 2016	3	download
Oct 7, 2015	2	download
Jun 20, 2014	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1369842	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN
2	1369842	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD
3	1369842	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY
4	1369842	acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY
5	1369842	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution	SY

Label: TOPCARE DAY TIME COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Other information

Questions?

Find additional resources

Safety

Related Resources

More Info on this Drug

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

	NDC
1	36800-603-34
2	36800-603-40

Label: TOPCARE DAY TIME COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Other information

Questions?

Find additional resources

Safety

Related Resources

More Info on this Drug

TOPCARE DAY TIME COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Number of versions: 9

TOPCARE DAY TIME COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

TOPCARE DAY TIME COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

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TOPCARE DAY TIME COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.