Cherry Night-time Multi-symptom Cold/flu Relief

Cherry Night-time Multi-symptom Cold/flu Relief
SPL v7
SPL
SPL Set ID 4c98b5bd-be18-4334-b6c7-bf51cd8ccb00
Route
ORAL
Published
Effective Date 2023-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (30 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 4 Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Citrate Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-11-19

Description

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg

Purpose

Pain reliver/fever reducer Cough suppressant Antihistamine


Medication Information

Warnings and Precautions

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 for this product ■ with other drugs containing

acetaminophen ■ 3 or more alcoholic drinks every day 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 two

days, is accompanied or followed by fever, headache, rash, nausea, or vomiting,

consult a doctor promptly.

Purpose

Pain reliver/fever reducer

Cough suppressant

Antihistamine

Description

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg

Uses

temporarily relieves cold/flu symptoms

  • sore throat
  • headache
  • minor aches and pain
  • fever
  • runny nose and sneezing
  • cough due to minor throat annd bronchial iritation
Section 50565-1

Keep out of reach of children.

Directions
  • take only as recommended-see Overdose warning
  • Use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
  • if taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours.
 adults and children 12 years and over  30 mL (2TBSP) every 6 hours
 children 4 to under 12 years  ask a doctor
 children under 4 years  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 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.
  • to make a child sleepy
Drug Facts

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

Questions?

Call weekdays 1-877-798-5944

Other Information
  • each 30mL dose cup contains:sodium 45 mg
  • store at room temperature
Overdose Warning:

Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help, or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms

Inactive Ingredients

citric acid, FD and C Blue No. 1, FD and C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

When Using This Product
  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If
  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Before Use If You Have
  • a sodium restricted diet
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland.
Ask A Doctor Or Pharmacist Before Use
  • if you are taking sedatives or tranquilizers
  • if you are taking the blood thinning drug warfarin.
Discount Drug Mart Food Fair Cherry Night Time Multi Symptom Cold/flu Relief Product Label

*COMPARE TO THE ACTIVE INGREDIENTS IN VICKS ®NYQUIL ®

DISCOUNT

drug mart

FOOD FAIR

Cherry

Night-Time Multi-Symptom Cold/Flu Relief

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

Dextromethorphan HBR ....... Cough Suppressant

Doxylamine Succinate ........... Antihistamine

12 FL OZ (354 mL)

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

LR-066   REV 01

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

temporarily relieves cold/flu symptoms

  • sore throat
  • headache
  • minor aches and pain
  • fever
  • runny nose and sneezing
  • cough due to minor throat annd bronchial iritation
Warnings and Precautions (34071-1)

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 for this product ■ with other drugs containing

acetaminophen ■ 3 or more alcoholic drinks every day 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 two

days, is accompanied or followed by fever, headache, rash, nausea, or vomiting,

consult a doctor promptly.

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Pain reliver/fever reducer

Cough suppressant

Antihistamine

Directions
  • take only as recommended-see Overdose warning
  • Use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
  • if taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours.
 adults and children 12 years and over  30 mL (2TBSP) every 6 hours
 children 4 to under 12 years  ask a doctor
 children under 4 years  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 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.
  • to make a child sleepy
Drug Facts

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

Questions?

Call weekdays 1-877-798-5944

Other Information (Other information)
  • each 30mL dose cup contains:sodium 45 mg
  • store at room temperature
Overdose Warning: (Overdose warning:)

Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help, or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms

Inactive Ingredients (Inactive ingredients)

citric acid, FD and C Blue No. 1, FD and C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

When Using This Product (When using this product)
  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • 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)
  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a sodium restricted diet
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland.
Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)
  • if you are taking sedatives or tranquilizers
  • if you are taking the blood thinning drug warfarin.
Discount Drug Mart Food Fair Cherry Night Time Multi Symptom Cold/flu Relief Product Label (DISCOUNT drug mart FOOD FAIR Cherry Night-Time Multi-Symptom Cold/Flu Relief product label)

*COMPARE TO THE ACTIVE INGREDIENTS IN VICKS ®NYQUIL ®

DISCOUNT

drug mart

FOOD FAIR

Cherry

Night-Time Multi-Symptom Cold/Flu Relief

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

Dextromethorphan HBR ....... Cough Suppressant

Doxylamine Succinate ........... Antihistamine

12 FL OZ (354 mL)

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

LR-066   REV 01

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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