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TopCare Mucus Relief and Cold and Flu

Medically reviewed on Nov 20, 2017

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Topco Associates LLC
NDC Code: 36800-951

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. Mucus Relief & Cold & Flu Drug Facts

Active ingredients (in each caplet) - DAY TIME Severe Cold

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active ingredients (in each caplet) – NIGHT TIME Cold & Flu

Acetaminophen 325 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 5 mg

Purposes - DAY TIME Severe Cold

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Purposes - NIGHT TIME Cold & Flu

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses
temporarily relieves these common cold and flu symptoms:
nasal congestion
cough (DAY TIME Severe Cold only)
minor aches and pains
headache
sore throat
runny nose and sneezing (NIGHT TIME Cold & Flu only)
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME Severe Cold only)
temporarily reduces fever

Warnings

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

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

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.
with any other product containing diphenhydramine, even one used on skin (NIGHT TIME Cold & Flu only)
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

Ask a doctor before use if you have
liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
glaucoma (NIGHT TIME Cold & Flu only)
a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME Cold & Flu only)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (DAY TIME Severe Cold only)
cough that occurs with too much phlegm (mucus) (DAY TIME Severe Cold only)

Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
taking sedatives or tranquilizers (NIGHT TIME Cold & Flu only)

When using these products
do not use more than directed
excitability may occur, especially in children (NIGHT TIME Cold & Flu only)
marked drowsiness may occur (NIGHT TIME Cold & Flu only)
alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME Cold & Flu only)
avoid alcoholic drinks (NIGHT TIME Cold & Flu only)
be careful when driving a motor vehicle or operating machinery (NIGHT TIME Cold & Flu only)

Stop use and ask a doctor if
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. (DAY TIME Severe Cold only)

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
do not take more than directed (see overdose warning)
do not take more than 10 caplets in any 24-hour period
adults and children 12 years of age and older: take 2 caplets every 4 hours
children under 12 years of age: do not use

Other information
each caplet contains: sodium 4 mg (DAY TIME Severe Cold only)
store at 20-25°C (68-77°F)

Inactive ingredients- DAY TIME Severe Cold

croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Inactive ingredients – NIGHT TIME Cold & Flu

crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

Mucus Relief

Severe Congestion & Cold

Maximum Strength

Mucus Relief

Severe Congestion & Cold

PAIN RELIEVER – FEVER REDUCER

Acetaminophen

COUGH SUPPRESSANT

Dextromethorphan HBr

EXPECTORANT

Guaifenesin

NASAL DECONGESTANT

Phenylephrine HCl

Relieves aches, fever & sore throat

Controls cough

Relieves nasal & chest congestion

Thins & loosens mucus

SEE NEW WARNINGS

actual size

FOR AGES 12 +

COMPARE TO MUCINEX® FAST-MAX® DAY TIME SEVERE COLD active ingredients

20 CAPLETS

Cold & Flu

Night Time

MAXIMUM STRENGTH

Cold & Flu

Night Time

PAIN RELIEVER – FEVER REDUCER

Acetaminophen

ANTIHISTAMINE

Diphenhydramine HCl

NASAL DECONGESTANT

Phenylephrine HCl

Relieves aches, fever & sore throat

Relieves nasal congestion

Relieves runny nose & sneezing

SEE NEW WARNINGS

actual size

FOR AGES 12+

COMPARE TO MUCINEX® FAST-MAX® NIGHT TIME COLD & FLU active ingredients

10 CAPLETS

TOPCARE MUCUS RELIEF AND COLD AND FLU 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, diphenhydramine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-951
Packaging
#Item CodePackage Description
1NDC:36800-951-811 KIT in 1 PACKAGE
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 110 BLISTER PACK 20 
Part 25 BLISTER PACK 10 
Part 1 of 2
TOPCARE MUCUS RELIEF  SEVERE CONGESTION AND COLD
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONES 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize20mm
FlavorImprint CodeL922
Contains    
Packaging
#Item CodePackage Description
110 BLISTER PACK in 1 PACKAGE
12 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/28/2013
Part 2 of 2
TOPCARE COLD AND FLU NIGHT TIME 
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONES 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
15 BLISTER PACK in 1 PACKAGE
12 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/24/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/24/2014
Labeler - Topco Associates LLC (006935977)

 
Topco Associates LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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