Daytime Cold & Flu Relief, 24/7 Life By

Daytime Cold & Flu Relief, 24/7 Life By
SPL v2
SPL
SPL Set ID 2771d699-3f70-4318-e063-6394a90a89cc
Route
ORAL
Published
Effective Date 2022-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Acetaminophen (325 mg) Phenylephrine (5 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Sorbitol Trisodium Citrate Dihydrate Saccharin Sodium Polyethylene Glycol, Unspecified Propylene Glycol Sodium Benzoate Water Sodium Metabisulfite Anhydrous Citric Acid Glycerin Sucralose

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-04-19 Until 2028-08-25

Description

Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Uses

Uses

  • temporarily relieves common cold and flu symptoms:
  • sore throat
  • nasal congestion
  • minor aches and pains
  • headache
  • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
Section 51945-4

24/7 Life

BY 7-ELEVEN TM

Cold & Flu

DayTime Relief

Acetaminophen / Pain Reliever/Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Phenylephrine HCl / Nasal Decongestant

Relieves: Headache, Fever, Sore

Throat, Minor Aches & Pains,

Nasal Congestion, Cough

Ages 6 Years

and Over

compare to Vicks ®

DayQuil ® Cold & Flu


active ingredients*

12 FL OZ

(355 mL)

Menthol

Flavor

[imsge of mentha avensis leaf]

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 4 hours
children 6 to under 12 years 15 mL every 4 hours
children under 6 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

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product
Other Information

Other information

  • each 15 mL contains: sodium 13 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 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 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, FD&C yellow #6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium etabisulfite, sodium saccharin, sorbitol, sucralose

Questions Or Comments?

Questions or comments? 1-877-507-6516 (8 AM – 4:30PM CST)

Ask A Doctor Before Use

Ask a doctor before use if the user has

  • difficulty in urination due to enlargement of the prostate
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • heart disease
  • diabetes
  • thyroid disease
  • liver disease
  • high blood pressure
When Using This Product

When using this product do not exceed recommended dosage.

Stop Use and Ask A Doctor

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • 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. 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.

Ask A Doctor Or Pharmacist Before Use

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.


Structured Label Content

Uses

Uses

  • temporarily relieves common cold and flu symptoms:
  • sore throat
  • nasal congestion
  • minor aches and pains
  • headache
  • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
Section 51945-4 (51945-4)

24/7 Life

BY 7-ELEVEN TM

Cold & Flu

DayTime Relief

Acetaminophen / Pain Reliever/Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Phenylephrine HCl / Nasal Decongestant

Relieves: Headache, Fever, Sore

Throat, Minor Aches & Pains,

Nasal Congestion, Cough

Ages 6 Years

and Over

compare to Vicks ®

DayQuil ® Cold & Flu


active ingredients*

12 FL OZ

(355 mL)

Menthol

Flavor

[imsge of mentha avensis leaf]

Purpose

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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 4 hours
children 6 to under 12 years 15 mL every 4 hours
children under 6 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

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product
Other Information (Other information)

Other information

  • each 15 mL contains: sodium 13 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 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 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, FD&C yellow #6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium etabisulfite, sodium saccharin, sorbitol, sucralose

Questions Or Comments? (Questions or comments?)

Questions or comments? 1-877-507-6516 (8 AM – 4:30PM CST)

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

Ask a doctor before use if the user has

  • difficulty in urination due to enlargement of the prostate
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • heart disease
  • diabetes
  • thyroid disease
  • liver disease
  • high blood pressure
When Using This Product (When using this product)

When using this product do not exceed recommended dosage.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • 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)

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.

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

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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