Market Basket Day-time - 506

Market Basket Day-time - 506
SPL v3
SPL
SPL Set ID ce900e42-d0c8-408d-a1c3-3a9bef1c97ee
Route
ORAL
Published
Effective Date 2023-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Yellow No. 6 Glycerin Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-09-12

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCL 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCL 5 mg

Uses

Uses

temporarily relieves these common cold/flu symptoms:

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

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

  • more than 4 doses 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.

Allergy Alert: Acetaminophen may causesevere skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reactions occurs, stop 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

Directions

  • take only as recommended (see overdose warning)
  • use dosage cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours





age                                                                                                         dose

adults and children 12 years and over                                                        30 mL (2 TBSP) every 4 hours

children 6 years to under 12 years                                                             15 mL (1 TBSP) every 4 hours

children 4 years to  under 6 years                                                              ask a doctor

children under 4 years                                                                              do not use

  • When using Day Time and Night Time products, carefully read each label to ensure correct dosing.
Do Not Use

Do not use

  • 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacists.
Drug Facts



Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCL 5 mg

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Product Label

MARKET BASKET ®

“MORE FOR YOUR DOLLAR”

*COMPARE TO THE ACTIVE INGREDIENTS IN VICKS ®

DAYQUIL ®

DAY-TIME

COLD AND FLU RELIEF

Acetaminophen……Pain Reliever/Fever Reducer

Dextromethorphan HBr……Cough Suppressant

Phenylephrine HCL ……. Nasal Decongestant

12 FL OZ (354 ML)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences

*This product is not manufactured or distributed by Proctor and Gamble, owner of the registered trademark Vicks® Dayquil®.

DISTRIBUTED BY DEMOULAS SUPERMARKETS INC.

875 EAST STREET

TEWKSBURY, MA 01876

LR-036

LOT:                EXP:

res

Overdose Warning

Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information

  • sodium content per tablespoon: 10 mg
  • store at room temperature
Inactive Ingredients

citric acid, FD and C Yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucrose

When Using This Product

  • do not use more than directed (see overdose warning)
  • avoid alcoholic drinks
Stop Use and Ask A Doctor If

  • you get nervous, dizzy, or sleepless
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If Pregnant of Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

Keep this and all drugs out of the reach of children.

Ask A Doctor Before Use If You Have Ask A Doctor Or Pharmacist

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use



if the user is taking the blood thinning drug warfarin


Structured Label Content

Uses

Uses

temporarily relieves these common cold/flu symptoms:

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

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Warnings

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

  • more than 4 doses 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.

Allergy Alert: Acetaminophen may causesevere skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reactions occurs, stop 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

Directions

  • take only as recommended (see overdose warning)
  • use dosage cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours





age                                                                                                         dose

adults and children 12 years and over                                                        30 mL (2 TBSP) every 4 hours

children 6 years to under 12 years                                                             15 mL (1 TBSP) every 4 hours

children 4 years to  under 6 years                                                              ask a doctor

children under 4 years                                                                              do not use

  • When using Day Time and Night Time products, carefully read each label to ensure correct dosing.
Do Not Use (Do not use)

Do not use

  • 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacists.
Drug Facts



Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCL 5 mg

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Product Label

MARKET BASKET ®

“MORE FOR YOUR DOLLAR”

*COMPARE TO THE ACTIVE INGREDIENTS IN VICKS ®

DAYQUIL ®

DAY-TIME

COLD AND FLU RELIEF

Acetaminophen……Pain Reliever/Fever Reducer

Dextromethorphan HBr……Cough Suppressant

Phenylephrine HCL ……. Nasal Decongestant

12 FL OZ (354 ML)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences

*This product is not manufactured or distributed by Proctor and Gamble, owner of the registered trademark Vicks® Dayquil®.

DISTRIBUTED BY DEMOULAS SUPERMARKETS INC.

875 EAST STREET

TEWKSBURY, MA 01876

LR-036

LOT:                EXP:

res

Overdose Warning

Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information (Other information)

  • sodium content per tablespoon: 10 mg
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

citric acid, FD and C Yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucrose

When Using This Product (When using this product)

  • do not use more than directed (see overdose warning)
  • avoid alcoholic drinks
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

  • you get nervous, dizzy, or sleepless
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If Pregnant of Breast Feeding (If pregnant of breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

Keep this and all drugs out of the reach of children.

Ask A Doctor Before Use If You Have Ask A Doctor Or Pharmacist (Ask a doctor before use if you have Ask a doctor or pharmacist)

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use



if the user is taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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