Nighttime Cold & Flu, 24-7 Life By

Nighttime Cold & Flu, 24-7 Life By
SPL v2
SPL
SPL Set ID 277363f4-1c00-ddb7-e063-6294a90a4677
Route
ORAL
Published
Effective Date 2022-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (30 mg) Acetaminophen (650 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Green No. 3 Sucralose Trisodium Citrate Dihydrate Propylene Glycol Sodium Saccharin Fd&c Yellow No. 6 Water Glycerin Polyethylene Glycol, Unspecified Sodium Chloride High Fructose Corn Syrup Sodium Benzoate D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-04-19 Until 2028-12-02

Description

Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Purpose

​Purpose Pain reliever/fever reducer Cough suppressant Antihistamine


Medication Information

Purpose

​Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Description

Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Uses

Uses

  • temporarily relieves common cold and flu symptoms:
  • runny nose and sneezing
  • minor aches and pains
  • headache
  • sore throat
  • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
Directions

Directions

  • do not take more than directed
  • mL = milliliter
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hours
  • adults and children 12 years and over: 30 mL every 6 hours
  • children under 12 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 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Allergy Alert

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.

Liver Warning

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Other Information

Other information

  • each 30 mL contains: sodium 22 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
Active Ingredients

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Sore Throat Warning

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.

Inactive Ingredients

Inactive ingredients

anhydrous citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6, flavors, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sucralose

Questions Or Comments?

Questions or comments?

1-877-507-6516 (8AM - 4:30PM CST)

Ask A Doctor Before Use

Ask a doctor before use if you have

  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)
  • liver disease
  • glaucoma
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
When Using This Product

When using this product

  • excitability may occur, especially in children
  • avoid alcoholic beverages
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 7 days
  • 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.

Ask A Doctor Or Pharmacist

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Nighttime Cold & Flu, 24 7 Life By

24/7 life

BY 7-ELEVEN

Cold&Flu

Nighttime Relief

Acetaminophen / Pain Reliever/Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Doxylamine Succinate / Antihistamine

Relieves: Headache, Fever, Sore

Throat, Minor Aches & Pains,

Sneezing, Runny Nose, Cough

Ages 12 Years

and Over

compare to Vicks®

NyQuil® Cold & Flu


active ingredients*

12 FL OZ

(355 mL)

Eucalyptus

Mint Flavor

[image of eucalyptus leaves]


Structured Label Content

Uses

Uses

  • temporarily relieves common cold and flu symptoms:
  • runny nose and sneezing
  • minor aches and pains
  • headache
  • sore throat
  • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
Purpose

​Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Directions

Directions

  • do not take more than directed
  • mL = milliliter
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hours
  • adults and children 12 years and over: 30 mL every 6 hours
  • children under 12 years: do not use
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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Allergy Alert (Allergy alert)

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.

Liver Warning (Liver warning)

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Other Information (Other information)

Other information

  • each 30 mL contains: sodium 22 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
Active Ingredients (Active ingredients)

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Sore Throat Warning (Sore throat warning)

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.

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

anhydrous citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6, flavors, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sucralose

Questions Or Comments? (Questions or comments?)

Questions or comments?

1-877-507-6516 (8AM - 4:30PM CST)

Ask A Doctor Before Use (Ask a doctor before use)

Ask a doctor before use if you have

  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)
  • liver disease
  • glaucoma
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
When Using This Product (When using this product)

When using this product

  • excitability may occur, especially in children
  • avoid alcoholic beverages
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 7 days
  • 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.

Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
If Pregnant Or Breast Feeding (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 out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Nighttime Cold & Flu, 24 7 Life By (Nighttime Cold & Flu, 24-7 Life BY)

24/7 life

BY 7-ELEVEN

Cold&Flu

Nighttime Relief

Acetaminophen / Pain Reliever/Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Doxylamine Succinate / Antihistamine

Relieves: Headache, Fever, Sore

Throat, Minor Aches & Pains,

Sneezing, Runny Nose, Cough

Ages 12 Years

and Over

compare to Vicks®

NyQuil® Cold & Flu


active ingredients*

12 FL OZ

(355 mL)

Eucalyptus

Mint Flavor

[image of eucalyptus leaves]


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)