Family Dollar Daytime Cold And Flu Relief

Family Dollar Daytime Cold And Flu Relief
SPL v1
SPL
SPL Set ID cef63000-9df2-4312-afbd-f932d7ebc112
Route
ORAL
Published
Effective Date 2023-07-26
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 Edetate Disodium Fd&c Yellow No. 6 Glycerin Menthol, Unspecified Form Potassium Citrate Anhydrous Propyl Gallate Propylene Glycol Water Sodium Benzoate Sodium Chloride Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-07-07

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Uses
  •  
    temporarily relieves common cold/flu symptoms:
  •  
Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Warnings

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

  • adult takes more than 4 doses (30 mL) in 24 hours which is maximum daily amount for this product
  • child takes more than 4 doses (15 mL) in 24 hours, which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

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.

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.

Directions
  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hours

Adults & children 12 yrs & over

30 mL every 4 hrs.

Children 6 to under 12 yrs

15 mL every 4 hrs

Children 4 to under 6 yrs

Ask a doctor

Children under 4 yrs.

Do not use

Do Not Use
  • with any other drug containing acetaminophen (prescription or non-prescription). 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. 
Other Information
  • each 15 mL contains: sodium 42 mg 
  • store at room temperature. Do not refrigerate
Inactive Ingredients

Anhydrous citric acid, disodium edetate, FD&C Yellow No 6, flavor, glycerin, menthol, potassium citrate, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-866-467-2748

Principal Display Panel

Compare to the active ingredients in Vicks® Dayquil™ Cold & Flu*

NDC 55319-912-12

Day Time

Cold & Flu Relief 

Acetaminophen, Phenylephrine HCI,

Dextromethorphan HBr

  • Headache, Fever, Sore Throat, Minor Aches & Pains
  • Nasal congestion & Sinus Pressure
  • Cough

12 FL OZ (354 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Distributed by:

*This product.is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® Dayquil™ Cold & Flu.

When Using This Product,

do not use more than directed.

Stop Use and Ask A Doctor If
  • you get nervous, dizzy, or sleepless
  • pain, nasal congestion, or cough gets worse, or lasts more than 5 days (children) or 7 days (adults) 
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur 
  • cough comes back or occurs with a 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.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each 15 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.


Structured Label Content

Uses
  •  
    temporarily relieves common cold/flu symptoms:
  •  
Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Warnings

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

  • adult takes more than 4 doses (30 mL) in 24 hours which is maximum daily amount for this product
  • child takes more than 4 doses (15 mL) in 24 hours, which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

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.

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.

Directions
  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hours

Adults & children 12 yrs & over

30 mL every 4 hrs.

Children 6 to under 12 yrs

15 mL every 4 hrs

Children 4 to under 6 yrs

Ask a doctor

Children under 4 yrs.

Do not use

Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or non-prescription). 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. 
Other Information (Other information)
  • each 15 mL contains: sodium 42 mg 
  • store at room temperature. Do not refrigerate
Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, disodium edetate, FD&C Yellow No 6, flavor, glycerin, menthol, potassium citrate, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel

Compare to the active ingredients in Vicks® Dayquil™ Cold & Flu*

NDC 55319-912-12

Day Time

Cold & Flu Relief 

Acetaminophen, Phenylephrine HCI,

Dextromethorphan HBr

  • Headache, Fever, Sore Throat, Minor Aches & Pains
  • Nasal congestion & Sinus Pressure
  • Cough

12 FL OZ (354 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Distributed by:

*This product.is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® Dayquil™ Cold & Flu.

When Using This Product, (When using this product,)

do not use more than directed.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you get nervous, dizzy, or sleepless
  • pain, nasal congestion, or cough gets worse, or lasts more than 5 days (children) or 7 days (adults) 
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur 
  • cough comes back or occurs with a 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each 15 Ml) (Active ingredients (in each 15 mL))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

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