walgreens high blood pressure nighttime cold & flu

walgreens high blood pressure nighttime cold & flu
SPL v4
SPL
SPL Set ID f1b7b58f-bbc3-441f-926f-d66e6a9b4e3a
Route
oral
Published
Effective Date 2023-03-21
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 edetate disodium fd&c blue no. 1 fd&c red no. 40 propyl gallate propylene glycol water sodium benzoate sodium citrate, unspecified form sorbitol sucralose

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-03-03

Description

Drug Facts


Medication Information

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing
Directions
  • take only as directed
  • use dose cup provided
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL per dose every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other Information
  • each 30 mL contains:sodium16 mg
  • store at room temperature
Inactive Ingredients

Anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Description

Drug Facts

Questions?

1-866-467-2748

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredients (in each 30 mL dose cup) Purpose

Acetaminophen 650 mg

Pain reliever/fever reducer

Dextromethorphan HBr 30 mg

Cough suppressant

Doxylamine succinate 12.5 mg

Antihistamine

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.
Liver Warning

This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 4 doses (30 mL each dose) 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
Overdose Warning

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

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.

When Using This Product
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
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 Before Use If You Have
  • 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
Principal Display Panel 236 Ml Bottle Label

Compare to the active ingredients in Vicks ®NyQuil™ High Blood Pressure Cold & Flu*

NDC 0363-6210-08

High Blood

Pressure

Nighttime

Cold & Flu

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat,

Minor Aches & Pains

Sneezing, Runny Nose

Cough

Sugar Free & No Added Alcohol

8 FL OZ (236 mL)

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

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing
Directions
  • take only as directed
  • use dose cup provided
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL per dose every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other Information (Other information)
  • each 30 mL contains:sodium16 mg
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Questions?

1-866-467-2748

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each 30 mL dose cup) Purpose

Acetaminophen 650 mg

Pain reliever/fever reducer

Dextromethorphan HBr 30 mg

Cough suppressant

Doxylamine succinate 12.5 mg

Antihistamine

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.
Liver Warning (Liver warning)

This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 4 doses (30 mL each dose) 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
Overdose Warning (Overdose warning)

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

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.

When Using This Product (When using this product)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • 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)
  • 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 Before Use If You Have (Ask a doctor before use if you have)
  • 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
Principal Display Panel 236 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label)

Compare to the active ingredients in Vicks ®NyQuil™ High Blood Pressure Cold & Flu*

NDC 0363-6210-08

High Blood

Pressure

Nighttime

Cold & Flu

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat,

Minor Aches & Pains

Sneezing, Runny Nose

Cough

Sugar Free & No Added Alcohol

8 FL OZ (236 mL)

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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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