Orange Day-time Cold/flu Relief

Orange Day-time Cold/flu Relief
SPL v7
SPL
SPL Set ID 426db906-9aa4-448f-a361-09c1516efc25
Route
ORAL
Published
Effective Date 2023-11-14
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
Anhydrous Citric Acid Fd&c Yellow No. 6 Glycerin Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-25

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCL 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Warnings and Precautions

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 ● with other drugs containing

acetaminophen ● 3 or more alcoholic drinks everyday while using this product.

Allery Alert:Acetaminophen may cause severe skin reactions.

Symptoms may include: ● skin reddening ● blisters ● rash

If 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.

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCL 5 mg

Uses

temporaily relieves these common cold/flu symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • fever
  • nasal congestion
  • cough due to minor throat and bronchial irritation
Section 60561-8

DO NOT USE IF IMPRINTED SHRINK BRAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences.

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
  • if you are now taking a prescription monamine 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.
  • with any other drug containing acetaminophen (prescription or nonprescription) If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
Drug Facts

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCL 5 mg

Questions?

Call weekdays 1-877-798-5944

Other Information
  • sodium content per tablespoon: 10 mg
  • store at room temperature
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.

Inactive Ingredients

citric acid, FD and C Yellow # 6, flavor, glycerin, propylene glycol, prified 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) 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 Or 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
  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • persistant or chronic cough such as occur with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucuc)
Ask A Doctor Or Pharmacist Before Use If

the user is taking the blood thinner warfarin

Product Label: Discount Drug Mart Food Fair Orange Day Time Cold/flu Relief

*COMPARE TO THE ACTIVE INGREDIENTS IN VICKS ®DAYQUIL ®

DISCOUNT

drug mart

FOOD FAIR

Orange Day-Time Cold/Flu Relief

Acetaminophen ...... Pain Reliever/Fever Reducer

Dextromethorphan HBR ....... Cough Suppressant

Phenylephrine HCL ....... Nasal Decongestant

12 FL OZ (354 mL)

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

LR-064   REV 02

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256

res


Structured Label Content

Uses

temporaily 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 and Precautions (34071-1)

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 ● with other drugs containing

acetaminophen ● 3 or more alcoholic drinks everyday while using this product.

Allery Alert:Acetaminophen may cause severe skin reactions.

Symptoms may include: ● skin reddening ● blisters ● rash

If 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.

Section 60561-8 (60561-8)

DO NOT USE IF IMPRINTED SHRINK BRAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences.

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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 monamine 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.
  • with any other drug containing acetaminophen (prescription or nonprescription) If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
Drug Facts

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCL 5 mg

Questions?

Call weekdays 1-877-798-5944

Other Information (Other information)
  • sodium content per tablespoon: 10 mg
  • store at room temperature
Overdose Warning: (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.

Inactive Ingredients (Inactive ingredients)

citric acid, FD and C Yellow # 6, flavor, glycerin, propylene glycol, prified 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) 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 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)

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

Ask A Doctor Before Use If You Have (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
  • persistant or chronic cough such as occur with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucuc)
Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

the user is taking the blood thinner warfarin

Product Label: Discount Drug Mart Food Fair Orange Day Time Cold/flu Relief (Product Label: DISCOUNT drug mart FOOD FAIR Orange Day-Time COLD/FLU RELIEF)

*COMPARE TO THE ACTIVE INGREDIENTS IN VICKS ®DAYQUIL ®

DISCOUNT

drug mart

FOOD FAIR

Orange Day-Time Cold/Flu Relief

Acetaminophen ...... Pain Reliever/Fever Reducer

Dextromethorphan HBR ....... Cough Suppressant

Phenylephrine HCL ....... Nasal Decongestant

12 FL OZ (354 mL)

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

LR-064   REV 02

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256

res


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