OTC Medication Information: Topcare Day Time Cold and Flu

TOPCARE DAY TIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution
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.

Active ingredients (in each 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

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 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

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 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.

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 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.

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, xanthan gum

Questions or comments?

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COMPARE TO VICKS® DAYQUIL® SEVERE ACTIVE INGREDIENTS

MAXIMUM STRENGTH RELIEF

Day Time Cold & Flu

SEVERE

OUR PHARMACISTS RECOMMEND

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

day time cold and flu image
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
EDETATE DISODIUM
FD&C YELLOW NO. 6
GLYCERIN
MENTHOL, UNSPECIFIED FORM
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SUCROSE
XANTHAN GUM
Product Characteristics
Color ORANGE (clear) Score
Shape Size
Flavor FRUIT, MENTHOL Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-603-34 237 mL in 1 BOTTLE None
2 NDC:36800-603-40 355 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/13/2014
Labeler — Topco Associates LLC (006935977)

Revised: 01/2020 Topco Associates LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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