Grocery Outlet Nighttime Cold & Flu Cherry Liquid

Manufacturer
Grocery Outlet, Inc. | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2026-03-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:39

Key Label Information

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

OTC - PURPOSE SECTION

Purpose Pain reliever/fever reducer Cough suppressant Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take -more than 4 doses 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 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 only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over-30 mL 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 alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

Products

NDC Codes

Ingredients

Complete SPL Sections

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Purpose 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 and bronchial irritation -sore throat -headache -minor aches and pains -fever -runny nose and sneezing

WARNINGS SECTION

WARNINGS SECTION

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take -more than 4 doses 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 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 -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 -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

OTC - STOP USE SECTION

OTC - STOP USE SECTION

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.

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 (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.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

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 6 hrs children 4 to under 12 yrs-ask a doctor children under 4 yrs-do not use

OTHER SAFETY INFORMATION

OTHER SAFETY INFORMATION

Other information each 30 mL contains: sodium 52 mg store at no greater than 25°C and do not refrigerate

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive ingredients alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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