694T KROGER 41226 694 Acetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate CT 24

Manufacturer
Kroger Company | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2025-02-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:54:50

Key Label Information

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg Dextromethorphan Hydrobromide 15 mg Doxylamine succinate 6.25 mg

OTC - PURPOSE SECTION

Pain reliever/fever reducer Cough suppressant Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 softgels 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.

OTC - DO NOT USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Directions take only as directed 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 Label Information

INACTIVE INGREDIENT SECTION

Inactive ingredients FD&C Blue #1, D&C yellow #10,gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water,shellac, sorbitol sorbitan solution,titanium dioxide.

OTC - QUESTIONS SECTION

Questions ? 1-800-632-6900

Products

NDC Codes

Ingredients

Complete SPL Sections

DRUG FACTS

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg Dextromethorphan Hydrobromide 15 mg Doxylamine succinate 6.25 mg

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Pain reliever/fever reducer Cough suppressant Antihistamine

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

WARNINGS SECTION

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 softgels 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.

OTC - DO NOT USE SECTION

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes 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

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions take only as directed 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

SPL UNCLASSIFIED SECTION

Other information store at room temperature

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive ingredients FD&C Blue #1, D&C yellow #10,gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water,shellac, sorbitol sorbitan solution,titanium dioxide.

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

Questions ? 1-800-632-6900

Source Document

Official SPL XML cached by FDA.report ยท DailyMed PDF

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Legacy File Index

FolderFileDate
otc2dc8828e-abd9-8993-e063-6294a90afc8c.xml2025-02-12
otcec79e945-d60d-7590-e053-2a95a90a5cc4.xml2022-11-18
otcc076a2b6-d04f-68bf-e053-2995a90a07cb.xml2021-05-12
otcCold and flu Nighttime-24ct.jpg2021-05-12