Drug Facts

Set ID
f9b8dbe1-7ff9-4320-850c-6e86e98d4393
Manufacturer
Rite Aid Corporation
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:21:32

Key Label Information

Active Ingredients And Purpose

Active ingredients (in each 30 mL)

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Purposes

Pain reliever/fever reducer Cough suppressant Antihistamine

Uses

Uses

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

Warnings

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 doses of acetaminophen in 24 hours 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.

Directions And Dosage

Directions

do not take more than directed (see Overdose warning) do not take more than 4 doses in any 24-hours period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product adults and children 12 years and over: 30 mL every 6 hours children under 12 years of age: do not use When using other Day Time or Night Time products, carefully read each label to ensure correct dosing

Other Label Information

Other information

each 30 mL contains: potassium 5 mg each 30 mL contains: Sodium 24 mg store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

acesulfame potassium, alcohol, citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6,, flavor,high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Vicks® Nyquil® Cold and Flu* NIGHTTIME COLD & FLU RELIEF ACETAMINOPHEN 650 mg DEXTROMETHORPHAN HBr 30 mg DOXYLAMINE SUCCINATE 12.5 mg PAIN RELIEVER / FEVER REDUCER COUGH SUPPRESSANT ANTIHISTAMINE Relieves headache, fever, sore throat, minor aches & pains Sneezing • Runny nose • Cough 10% Alcohol For ages 12 years & over Nighttime relief FL OZ (mL) *This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING . DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011 www.riteaid.com

Products

NDC Codes

Ingredients

NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
ALCOHOL3K9958V90MIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C GREEN NO. 33P3ONR6O1SIACT
FD&C YELLOW NO. 6H77VEI93A8IACT

Complete SPL Sections

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer Cough suppressant Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 doses of acetaminophen in 24 hours 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.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed (see Overdose warning) do not take more than 4 doses in any 24-hours period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product adults and children 12 years and over: 30 mL every 6 hours children under 12 years of age: do not use When using other Day Time or Night Time products, carefully read each label to ensure correct dosing

Other information

STORAGE AND HANDLING SECTION

each 30 mL contains: potassium 5 mg each 30 mL contains: Sodium 24 mg store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, alcohol, citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6,, flavor,high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Vicks® Nyquil® Cold and Flu* NIGHTTIME COLD & FLU RELIEF ACETAMINOPHEN 650 mg DEXTROMETHORPHAN HBr 30 mg DOXYLAMINE SUCCINATE 12.5 mg PAIN RELIEVER / FEVER REDUCER COUGH SUPPRESSANT ANTIHISTAMINE Relieves headache, fever, sore throat, minor aches & pains Sneezing • Runny nose • Cough 10% Alcohol For ages 12 years & over Nighttime relief FL OZ (mL) *This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING . DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011 www.riteaid.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RITE AID Night time Cold & Flu

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc2dce2c3b-8c1f-43e6-a64e-3dc48834b838.xml2025-12-10
otcnighttime-cold-and-flu-original-liquid-delisted-1.jpg2025-12-10
otc86b9093a-1910-45f0-a89f-1f4200c84a87.xml2024-05-10
otc622aa1c6-9e2c-4ac7-a791-cb3722e2b6c6.xml2022-02-01
otcb5ad3100-2e0b-44b7-8047-dbc6fc368c33.xml2021-12-15
otcf3f1a5c9-8314-4319-be7d-594ae4f30754.xml2021-11-21
otca32e49aa-e1eb-424e-81cb-2dad982cb7d5.xml2020-03-14
otcnighttime-cold-and-flu-original-liquid-1.jpg2020-03-14