Daytime Cold & Flu High Blood Pressure

Daytime Cold & Flu High Blood Pressure
SPL v1
SPL
SPL Set ID 09fbd872-0970-4864-9308-4a7b85983920
Route
ORAL
Published
Effective Date 2025-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Yellow No. 6 Glycerin Propylene Glycol Water Sodium Saccharin Sodium Benzoate Anhydrous Trisodium Citrate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Drug Facts Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg


Medication Information

Indications and Usage

Uses

Temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
Description

Drug Facts Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

• pain or cough gets worse or last 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.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug Warfarin

Section 50569-3

Ask a doctor before use if you have • liver disease •cough that occurs with too much phlegm (mucus) • persistent or

chronic cough such as occurs with smoking, asthma or emphysema

Section 50570-1

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 two 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.

Section 51727-6

Inactive ingredients

citric acid, FD&C Yellow no. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate,

sodium citrate, sorbitol, sucralose, xanthan gum.

Section 53413-1

Questions? Call weekdays 1-888-588-1418

Section 55105-1

Purpose

Acetaminophen .................Pain reliever/Fever reducer

Dextromethorphan HBr ..........Cough suppressant

Section 55106-9

Drug Facts



Active ingredients

(in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Section 60561-8

​Other information

• sodium content per tablespoon: 23 mg

• store at room temperature

Warnings

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

  • more than 4 doses (30 mL each) of acetaminophen 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 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 dose cup provided
  • do not take more than 4 doses per 24 hours
Age                                                  Dose            
                                              adults and children 12 years and over                                                                               30 mL every 4  hours                              
children 4 to under 12 years 

ask a doctor                                       

children under 4 years  

do not use

If Pregnant Or Breast Feeding,

ask a health professional before use.

Package Label: Daytime Cold & Flu High Blood Pressure

------------------------

DAYTIME Cold & Flu High Blood Pressure

8 FL OZ (237 mL)

* This product is not manufactured or distributed by Proctor & Gamble, owner of the registered trademark Vicks®

DayQuil® High Blood Pressure Cold & Flu®.

Distributed by: Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA

res


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

• pain or cough gets worse or last 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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug Warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if you have • liver disease •cough that occurs with too much phlegm (mucus) • persistent or

chronic cough such as occurs with smoking, asthma or emphysema

Section 50570-1 (50570-1)

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 two 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.

Section 51727-6 (51727-6)

Inactive ingredients

citric acid, FD&C Yellow no. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate,

sodium citrate, sorbitol, sucralose, xanthan gum.

Section 53413-1 (53413-1)

Questions? Call weekdays 1-888-588-1418

Section 55105-1 (55105-1)

Purpose

Acetaminophen .................Pain reliever/Fever reducer

Dextromethorphan HBr ..........Cough suppressant

Section 55106-9 (55106-9)

Drug Facts



Active ingredients

(in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Section 60561-8 (60561-8)

​Other information

• sodium content per tablespoon: 23 mg

• store at room temperature

Warnings

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

  • more than 4 doses (30 mL each) of acetaminophen 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 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 dose cup provided
  • do not take more than 4 doses per 24 hours
Age                                                  Dose            
                                              adults and children 12 years and over                                                                               30 mL every 4  hours                              
children 4 to under 12 years 

ask a doctor                                       

children under 4 years  

do not use

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Package Label: Daytime Cold & Flu High Blood Pressure (Package Label: DAYTIME Cold & Flu High Blood Pressure)

------------------------

DAYTIME Cold & Flu High Blood Pressure

8 FL OZ (237 mL)

* This product is not manufactured or distributed by Proctor & Gamble, owner of the registered trademark Vicks®

DayQuil® High Blood Pressure Cold & Flu®.

Distributed by: Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA

res


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