Kroger Daytime And Nighttime Cold And Flu Softgel Kit
FDA Label NDC 30142-233

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Kroger Company for the product Kroger Daytime And Nighttime Cold And Flu Softgel (NDC 30142-233). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding daytime cold & flu, active ingredients (in each softgel), purposes, uses:, warnings:, otc - keep out of reach of children, overdosage, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Daytime Cold & Flu

Drug Facts

Active Ingredients (In Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purposes

Pain reliever / Fever reducer

Cough suppressant

Nasal decongestant

Pain reliever / Fever reducer

Cough suppressant

Antihistamine

Uses:

temporarily relieves common cold/flu symptoms:
• nasal congestion • cough due to minor throat & bronchial irritation • sore throat  • headache • minor aches & pains • fever

temporarily relieves common cold/flu symptoms:
• cough due to minor throat & bronchial irritation   • sore throat  • headache  • minor aches & pains  • fever  • runny nose & sneezing

Warnings:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4 doses in 24 hrs, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

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.

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 as occurs with smoking, asthma, or emphysema

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

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 get 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.

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

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take   • more than 4 doses in 24 hrs, which is the maximum daily amount for this product  • with other drugs containing acetaminophen  • 3 or more alcoholic drinks daily 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.

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.  • to make a child sleep

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

Ask a doctor or pharmacist before use if you are  • taking sedatives or tranquilizers  • taking the blood thinning drug warfarin

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

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Keep out of reach of children.

Overdosage

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions:

  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hrs
     adults & children 12 yrs & over 2 Softgels with water every 4 hrs
     children 4 to under 12 yrs ask a doctor
     children under 4 yrs do not use
    • take only as directed - see Overdose warning
    • do not exceed 4 doses per 24 hrs
    •  adults & children 12 yrs & over 2 Softgels with water every 6 hrs
       children 4 to under 12 yrs ask a doctor
       children under 4 yrs do not use

Other Information:

  • store at room temperature between 20-25 °C (68-77 °F)
    • store at room temperature between 20-25 °C (68-77 °F)

Inactive Ingredients:

Edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution

D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments:

1-800-632-6900

1-800-632-6900

Nighttime Cold & Flu

Drug Facts

Packaging

Kit Label (30142233)

Kit Label (30142233)

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