TOPCARE COLD MULTI SYMPTOM- acetaminophen, dextromethorphan hydrobromide, 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.

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Topco Cold Multi-Symptom Drug Facts

Active ingredient (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves these common cold/flu symptoms:
minor aches and pains
headache
sore throat
nasal congestion
cough
sinus congestion and pressure
helps clear nasal passages
promotes nasal and sinus drainage
temporarily reduces fever

Warnings

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

more than 12 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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.

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
cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
cough that occurs with too much phlegm (mucus)

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

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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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 Liver warning)

adults and children 12 years and over

take 2 caplets every 4 hours
swallow whole – do not crush, chew or dissolve
do not take more than 12 caplets in 24 hours

children under 12 years

do not use this adult product in children under

12 years of age

Inactive ingredients

acesulfame potassium, carnauba wax, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

See New Warnings Information

Daytime

Non-Drowsy

Cold

Multi-Symptom

Pain Reliever/Fever Reducer/Nasal Decongestant/Cough Suppressant

Contains 3 Medicines:
Fever/Headache/Sore Throat/Acetaminophen

Nasal Congestion/Phenylephrine HCl

Coughing/Dextromethorphan HBr

Instant Cooling Sensation

Cool Ice®

Actual Size

Compare to Tylenol® Cold Multi-Symptom Daytime active ingredients

Cold Multi-Symptom Carton

Cold Multi-Symptom Carton

Cold Multi-Symptom Carton

TOPCARE COLD MULTI SYMPTOM 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-371
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POVIDONES (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (caplet) Size17mm
FlavorVANILLA ((menthol)) Imprint Code L402
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-371-622 in 1 CARTON10/09/200710/09/2007
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/09/200710/09/2007
Labeler - Topco Associates LLC (006935977)

Revised: 8/2017
 
Topco Associates LLC