Kroger Daytime Severe Cold & Flu Honey Liquid

Kroger Daytime Severe Cold & Flu Honey Liquid
SPL v2
SPL
SPL Set ID 10b0fa3d-d6b2-272a-e063-6394a90a1205
Route
ORAL
Published
Effective Date 2024-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg) Acetaminophen (325 mg)
Inactive Ingredients
Glycerin Sodium Benzoate Fd&c Red No. 40 Water D&c Yellow No. 10 Polyethylene Glycol, Unspecified Sorbitol Solution Sucralose Xanthan Gum Fd&c Green No. 3 Fd&c Yellow No. 6 Citric Acid Monohydrate Sodium Citrate Propylene Glycol Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-30

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

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

  • adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
  • child takes more than 4 doses (15 mL each) in 24 hrs, 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.

Indications and Usage

Uses temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Dosage and Administration

Directions

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

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

Description

Drug Facts

Section 50565-1

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.

Section 50566-9

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 rash or headache that lasts.

These could be signs of a serious condition.

Section 50567-7

When using this product, do not use more than directed.

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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Section 50570-1

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.
Section 51727-6

Inactive ingredients citric acid monohydrate, D&C yellow no. 10, FD&C green no. 3, FD&C red no. 40, FD&C yellow no. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum

Section 51945-4

Section 53413-1

Questions or comments? Call 1-800-632-6900

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Section 55106-9

Active ingredients (in each 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Section 60561-8

Other information

  • each 15 mL contains: sodium 14 mg
  • store at no greater than 25℃ and do not refrigerate
Drug Facts

Drug Facts


Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Dosage and Administration (34068-7)

Directions

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

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

Warnings and Precautions (34071-1)

Warnings

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

  • adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
  • child takes more than 4 doses (15 mL each) in 24 hrs, 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.

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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 rash or headache that lasts.

These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product, do not use more than directed.

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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Section 50570-1 (50570-1)

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.
Section 51727-6 (51727-6)

Inactive ingredients citric acid monohydrate, D&C yellow no. 10, FD&C green no. 3, FD&C red no. 40, FD&C yellow no. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-632-6900

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Section 60561-8 (60561-8)

Other information

  • each 15 mL contains: sodium 14 mg
  • store at no greater than 25℃ and do not refrigerate
Drug Facts

Drug Facts


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)