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Top Care Day Time

Topco Associates LLC

Topco Associates LLC. Day Time Cold & Flu Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 15 ml tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Top Care Day Time Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever

Warnings

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

  • adult/child takes more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is 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
  • 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 as occurs with smoking, asthma, 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

  • 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.

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 Liver warning
  • use dose cup
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over 30 ml (2 TBSP) every 4 hrs
children 6 to under 12 yrs 15 ml (1 TBSP) every 4 hrs
children 4 to under 6 yrs ask a doctor
children under 4 yrs do not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Top Care Day Time Other information

  • each tablespoon contains: sodium 7 mg
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions or comments?

1-888-423-0139

Principal Display Panel

See New Warnings and Dosing Information

MULTI-SYMPTOM RELIEF

Day Time Cold & Flu

Relief

Pain Reliever/Fever Reducer - Acetaminophen

Cough Suppressant/Dextromethorphan HBr

Nasal Decongestant/Phenylephrine HCl

ORIGINAL FLAVOR

COMPARE TO VICKS® DAYQUIL® active ingredients

Alcohol Free

Antihistamine Free

Non-Drowsy

Top Care Day Time
Day Time Cold & Flu Label Image 1 Day Time Cold & Flu Label Image 2

Top Care Day Time

acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-656
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
EDETATE DISODIUM
FD&C YELLOW NO. 6
GLYCERIN
MENTHOL
sodium phosphate, monobasic
POLYETHYLENE GLYCOLS
propylene glycol
water
SACCHARIN SODIUM DIHYDRATE
SUCROSE
XANTHAN GUM

Product Characteristics

Color
ORANGE (clear)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-656-30 177 in 1 BOTTLE
2 NDC:36800-656-38 296 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2006-07-17


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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