TOPCARE DAY TIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, fi

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
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Authorization status:
OTC monograph final
Authorization number:
36800-581-62

TOPCARE DAY TIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide,

guaifenesin, phenylephrine hydrochloride tablet, film coated

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 Time Cold & Flu Drug Facts

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpos e

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Us es

Warnings

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

temporarily relieves common cold/flu symptoms:

nasal congestion

sinus congestion and pressure

cough due to minor throat and bronchial irritation

minor aches and pains

headache

fever

sore throat

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

more than 4,000 mg of acetaminophen in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

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

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

Ask a doctor before use if you have

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

If pregnant or breast-feeding,

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 this product.

if you have ever had an allergic reaction to this product or any of its ingredients

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, chronic bronchitis, or

emphysema

you get nervous, dizzy or sleepless

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.

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

adults & children 12 yrs & over

2 caplets with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

Inactive ingredients

croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, flavor, maltodextrin,

microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch,

propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

COMPARE TO VICKS DAYQUIL

SEVERE+ VAPOCOOL

ACTIVE INGREDIENTS

VAPOR ICE

DayTime Cold & Flu

SEVERE

OUR PHARMACISTS RECOMMEND

PAIN RELIEVER-FEVER REDUCER – ACETAMINOPHEN

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

EXPECTORANT – GUAIFENESIN

NASAL DECONGESTANT – PHENYLEPHRINE HCl

Minor Aches & Pains, Fever

Nasal Congestion & Sinus Pressure

take only as directed - see overdose warning

do not exceed 8 caplets per 24 hrs

each caplet contains: sodium 3 mg

store at 20-25°C (68-77°F)

Cough – Chest Congestion

Maximum Strength

Non-Drowsy

24 CAPLETS

actual size

TOPCARE DAY TIME COLD AND FLU

acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:36 8 0 0 -58 1

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

Topco Associates LLC

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

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

CRO SPO VIDO NE ( 15 MPA.S AT 5%) (UNII: 6 8 40 19 6 0 MK)

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

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )

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

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

ORANGE

S core

no sco re

S hap e

OVAL

S iz e

19 mm

Flavor

Imprint Code

L35C

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:36 8 0 0 -58 1-6 2 12 in 1 CARTON

0 9 /10 /20 19

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

0 9 /10 /20 19

Labeler -

T opco Associates LLC (006935977)

Revised: 9/2019

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