Topco Associates Llc. Nitetime Cold & Flu Drug Facts

Topco Associates Llc. Nitetime Cold & Flu Drug Facts
SPL v4
SPL
SPL Set ID ef574f18-e28d-46bb-87fd-2f3b4df6dc68
Route
ORAL
Published
Effective Date 2024-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg) Phenylephrine (5 mg)
Inactive Ingredients
Anhydrous Citric Acid D&c Yellow No. 10 Edetate Disodium Fd&c Green No. 3 Fd&c Red No. 40 Fd&c Yellow No. 6 Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Chloride Sodium Citrate, Unspecified Form Sorbitol Solution Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-03

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine Succinate 6.25 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine Succinate 6.25 mg Phenylephrine HCl 5 mg

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
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.

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

1-888-423-0139

Other Information
  • each 15 mL contains: sodium 15 mg
  • store at 20-25°C (68-77°F)
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

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
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.

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.

Active Ingredients (in Each 15 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine Succinate 6.25 mg

Phenylephrine HCl 5 mg

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
Package/label Principal Display Panel

TopCare® health

COMPARE TO VICKS® NYQUIL® SEVERE HONEY FLAVOR ACTIVE INGREDIENTS

MAXIMUM STRENGTH RELIEF

Nite Time Cold & Flu

SEVERE

PAIN RELIEVER/FEVER REDUCER – ACETAMINOPHEN

NASAL DECONGESTANT – PHENYLEPHRINE HCl

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

ANTIHISTAMINE – DOXYLAMINE SUCCINATE

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

• Nasal/Sinus Congestion & Sinus Pressure

• Sneezing, Runny Nose

• Cough

12 FL OZ (355 mL)

HONEY FLAVOR

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Structured Label Content

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
Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

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.

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
Do Not Use (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.
  • to make a child sleepy
  • if you have ever had an allergic reaction to this product or any of its ingredients
Questions?

1-888-423-0139

Other Information (Other information)
  • each 15 mL contains: sodium 15 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients (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

When Using This Product (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
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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.

Active Ingredients (in Each 15 Ml) (Active ingredients (in each 15 mL))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine Succinate 6.25 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have (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
Package/label Principal Display Panel (Package/Label Principal Display Panel)

TopCare® health

COMPARE TO VICKS® NYQUIL® SEVERE HONEY FLAVOR ACTIVE INGREDIENTS

MAXIMUM STRENGTH RELIEF

Nite Time Cold & Flu

SEVERE

PAIN RELIEVER/FEVER REDUCER – ACETAMINOPHEN

NASAL DECONGESTANT – PHENYLEPHRINE HCl

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

ANTIHISTAMINE – DOXYLAMINE SUCCINATE

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

• Nasal/Sinus Congestion & Sinus Pressure

• Sneezing, Runny Nose

• Cough

12 FL OZ (355 mL)

HONEY FLAVOR

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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