SPL v6
SPL
SPL Set ID e243033b-6603-4c3e-a330-e7c7de51f69d
Route
ORAL
Published
Effective Date 2018-09-28
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 D&c Yellow No. 10 Fd&c Green No. 3 Fd&c Yellow No. 6 Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Citrate Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-21

Description

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine


Medication Information

Warnings and Precautions

DO NOT USE IF IMPRINTED SHRINK BRAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences.

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

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 and bronchial irritation
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 (2 TBSP) 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 30 mL 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, D and C yellow # 10, FD and C Green No. 3, FD and C Yellow No. 6,  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.
Keep Out of Reach of Children

Keep out of reach of children.

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 Original Night Time Multi Symptom Cold/flu Relief Product Label

*COMPARE TO THE ACTIVE INGREDIENTS IN VICKS ®NYQUIL ®

DISCOUNT

drug mart

FOOD FAIR

Original

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-065 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


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 and bronchial irritation
Warnings and Precautions (34071-1)

DO NOT USE IF IMPRINTED SHRINK BRAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences.

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

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 (2 TBSP) 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 30 mL 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, D and C yellow # 10, FD and C Green No. 3, FD and C Yellow No. 6,  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.
Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.

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 Original Night Time Multi Symptom Cold/flu Relief Product Label (DISCOUNT drug mart FOOD FAIR Original Night-Time Multi-Symptom Cold/Flu Relief product label)

*COMPARE TO THE ACTIVE INGREDIENTS IN VICKS ®NYQUIL ®

DISCOUNT

drug mart

FOOD FAIR

Original

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-065 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


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