TOPCARE DAY NIGHT- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
Topco Associates LLC
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever Cough suppressant Expectorant Nasal decongestant Pain reliever Cough suppressant Antihistamine Nasal decongestant
Authorization status:
OTC monograph final
Authorization number:
36800-573-90

TOPCARE DAY NIGHT- acetaminophen, dextromethorphan hydrobromide, guaifenesin,

phenylephrine hydrochloride, doxylamine succinate

Topco Associates LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Topco Associates LLC. Day Night Drug Facts

Active ingredients (in each liquid gel) - DAY

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purposes - DAY

Pain reliever

Cough suppressant

Expectorant

Nasal decongestant

Active ingredients (in each liquid gel) - NIGHT

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purposes - NIGHT

Pain reliever

Cough suppressant

Antihistamine

Nasal decongestant

Us es

temporarily relieves:

nasal congestion

headache

cough

minor aches and pains

sinus congestion and pressure

Warnings

Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take

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

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

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

runny nose and sneezing (NIGHT only)

temporarily 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 (DAY only)

more than 4,000 mg of acetaminophen in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using these products

skin reddening

blisters

rash

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 these products.

if you have ever had an allergic reaction to these products or any of their ingredients

liver disease

heart disease

diabetes

high blood pressure

thyroid disease

trouble urinating due to an enlarged prostate gland

glaucoma (NIGHT only)

a breathing problem such as emphysema or chronic bronchitis (NIGHT only)

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or

emphysema

cough that occurs with too much phlegm (mucus)

taking the blood thinning drug warfarin

taking sedatives or tranquilizers (NIGHT only)

When using these products

Stop use and ask a doctor if

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.

Directions

Other information

Inactive ingredients (DAY only)

edible ink*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone,

propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Inactive ingredients (NIGHT only)

D&C yellow #10, edible ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone,

propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-888-423-0139

do not use more than directed

excitability may occur, especially in children (NIGHT only)

marked drowsiness may occur (NIGHT only)

alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)

avoid alcoholic drinks (NIGHT only)

be careful when driving a motor vehicle or operating machinery (NIGHT only)

nervousness, dizziness, or sleeplessness occur

pain, nasal congestion or cough 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

cough comes back or occurs with rash or headache that lasts. These could be signs of a serious

condition.

do not take more than directed (see Overdose warning)

do not take more than 10 liquid gels in any 24-hour period

adults and children 12 years of age and older: take 2 liquid gels every 4 hours

children under 12 years of age: do not use

Package/Label Principal Display Panel

COMPARE TO MUCINEX SINUS-MAX DAY ACTIVE INGREDIENTS

MAXIMUM STRENGTH

Sinus Relief

PAIN RELIEVER – ACETAMINOPHEN

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

EXPECTORANT – GUAIFENESIN

NASAL DECONGESTANT – PHENYLEPHRINE HCl

Relieves Sinus Pressure, Headache & Congestion

Controls Cough

Thins & Loosens Mucus

OUR PHARMACISTS RECOMMEND

DAY TIME

FOR AGES 12+

FAST DISSOLVING LIQUID GELS!

actual size

16 LIQUID GELS (LIQUID FILLED CAPSULES)

COMPARE TO MUCINEX SINUS-MAX NIGHT ACTIVE INGREDIENTS

MAXIMUM STRENGTH

Sinus Relief

Night

PAIN RELIEVER – ACETAMINOPHEN

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

ANTIHISTAMINE – DOXYLAMINE SUCCINATE

NASAL DECONGESTANT – PHENYLEPHRINE HCl

Relieves Nasal Congestion, Sinus Pressure & Pain

Controls Cough

Relieves Runny Nose & Sneezing

OUR PHARMACISTS RECOMMEND

NIGHT TIME

FOR AGES 12+

FAST DISSOLVING LIQUID GELS!

actual size

8 LIQUID GELS (LIQUID FILLED CAPSULES)

TOPCARE DAY NIGHT

acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:36 8 0 0 -573

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:36 8 0 0 -573-9 0

1 in 1 KIT; Type 0 : No t a Co mbinatio n Pro duct

0 8 /15/20 19

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

8 BLISTER PACK

Pa rt 2

4 BLISTER PACK

Part 1 of 2

TOPCARE DAY

acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled

Product Information

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

10 mg

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ)

GUAIFENESIN

20 0 mg

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SO RBITAN (UNII: 6 O9 2ICV9 RU)

Product Characteristics

Color

ORANGE

S core

no sco re

S hap e

OVAL

S iz e

25mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

2 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

Part 2 of 2

TOPCARE NIGHT

acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule,

liquid filled

Product Information

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

10 mg

DO XYLAMINE SUCCINATE (UNII: V9 BI9 B5YI2) (DOXYLAMINE - UNII:9 5QB77JKPL)

DOXYLAMINE SUCCINATE

6 .25 mg

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SO RBITAN (UNII: 6 O9 2ICV9 RU)

Product Characteristics

Color

GREEN

S core

no sco re

S hap e

OVAL

S iz e

20 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

2 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Topco Associates LLC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 8 /15/20 19

Labeler -

T opco Associates LLC (006935977)

Revised: 8/2019

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