FDA Label for Topcare Honey Flavor Cold And Flu Relief

View Indications, Usage & Precautions

ACTIVE INGREDIENTS (IN EACH 15 ML)
PURPOSE
USES
WARNINGS
DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
WHEN USING THIS PRODUCT
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREAST-FEEDING,
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
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Topcare Honey Flavor Cold And Flu Relief Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each 15 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine Succinate 6.25 mg

Phenylephrine HCl 5 mg

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

•nasal congestion
•sinus congestion and pressure
•cough due to minor throat and bronchial irritation
•cough to help you sleep
•minor aches and pains
•headache
•fever
•sore throat
•runny nose and sneezing
•reduces swelling of nasal passages
•temporarily restores freer breathing through the nose
•promotes nasal and/or sinus drainage

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

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.

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 pharmacists before taking this product.
•to make a child sleepy
•if you have ever had an allergic reaction to this product or any of its ingredients

•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 emotion 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
•glaucoma
•thyroid disease
•diabetes
•high blood pressure
•trouble urinating due to an enlarged prostate gland
•cough that occurs with too much phlegm (mucus)
•a breathing problem such as emphysema or chronic bronchitis
•persistent or chronic cough such as occurs with smoking, asthma, or emphysema

•liver disease
•heart disease
•thyroid disease
•diabetes
•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
•taking sedatives or tranquilizers

taking the blood thinning drug warfarin

When Using This Product

•do not use more than directed
•excitability may occur, especially in children
•marked drowsiness may occur
•avoid alcoholic drinks
•be careful when driving a motor vehicle or operating machinery
•alcohol, sedatives, and tranquilizers may increase drowsiness

do not use more than directed

Stop Use And Ask A Doctor If

•you get nervous, dizzy or sleepless
•pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
•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.

•you get nervous, dizzy, or sleepless
•pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
•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

•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 15 mg
•store at 20-25^◦C (68-77^◦F)

•each 15 mL contains: sodium 15 mg
•store at 20-25^◦C (68-77^◦F). Do not refrigerate.

Inactive Ingredients

anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C green #3, FD&C red #40, FD&C yellow #6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

1-888-423-0139

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MAXIMUM STRENGTH RELIEF

DayTime Cold & Flu

SEVERE

PAIN RELIEVER/FEVER REDUCER – ACETAMINOPHEN

NASAL DECONGESTANT – PHENYLEPHRINE HCl

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

EXPECTORANT - GUAIFENESIN

• Headache, Fever, Sore Throat, Minor Aches & Pains

• Nasal/Sinus Congestion & Sinus Pressure

• Thins & Loosens Mucus

• Chest Congestion

• Cough

Non-Drowsy