Cold and Flu Nighttime Severe, 24-7 Life

Manufacturer
Lil' Drug Store products, Inc.
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:43:50

Key Label Information#

Active Ingredients And Purpose

Active Ingredients

Active Ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

Purpose

​Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Uses

Uses

Uses temporarily relieves common cold and flu symptoms: minor aches and pains sinus congestion and pressure sore throat fever headache nasal congestion cough due to minor throat and bronchial irritation cough to help you sleep runny nose and sneezing reduces swelling of nasal passages promotes nasal and/or sinus drainage temporarily restores freer breathing through the nose

Warnings

Warnings

​Warnings

Directions And Dosage

Directions

Directions do not take more than directed do not take more than 8 caplets in 24 hours adults and children 12 years and over: take 2 caplets with water every 4 hours children under 12 years: ask a doctor

Other Label Information

Inactive ingredients

Inactive ingredients black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

Questions or comments? 1-877-507-6516

Cold & Flu Nighttime Severe, 16ct, 24/7 Life - PDP/Package

[24/7 Life logo] Cold & Flu Nighttime Severe Acetaminophen / Pain Reliever/Fever Reducer Dextromethorphan HBr /Cough Suppressant Doxylamine Succinate / Antihistamine Phenylephrine HCl / Nasal Decongestant Relieves: Headache, Fever, Sore Throat, Minor Aches & Pains, Nasal Congestion, Sinus Pressure, Sneezing, Runny Nose, Cough compare to Vicks ® NyQuil ® VapoCOOL™ SEVERE Cold & Flu + Congestion active ingredients* 16 CAPLETS Actual Size [caplet image]

Label Images#

65168 7E Nighttime C + F 16ct_paint
65168 7E Nighttime C + F 16ct_paint

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1546881acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral TabletPSN2
1546881acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD2
1546881APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-6516-8Cold and Flu Nighttime Severe, 24-7 Life8 in 1 BLISTER PACKTABLET, FILM COATED82
66715-6516-8Cold and Flu Nighttime Severe, 24-7 Life2 in 1 CARTONTABLET, FILM COATED22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6516COLD AND FLU NIGHTTIME SEVERE, 24-7 LIFE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2Current NDC, 2 package rows20241218_05d0410f-164e-e7ee-e063-6394a90a2aaa.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-651666715-6516-8

Ingredients#

Complete SPL Sections#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

​Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Uses temporarily relieves common cold and flu symptoms: minor aches and pains sinus congestion and pressure sore throat fever headache nasal congestion cough due to minor throat and bronchial irritation cough to help you sleep runny nose and sneezing reduces swelling of nasal passages promotes nasal and/or sinus drainage temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

​Warnings

Directions

DOSAGE & ADMINISTRATION SECTION

Directions do not take more than directed do not take more than 8 caplets in 24 hours adults and children 12 years and over: take 2 caplets with water every 4 hours children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Other information each caplet contains: sodium 3 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments? 1-877-507-6516

Cold & Flu Nighttime Severe, 16ct, 24/7 Life - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[24/7 Life logo] Cold & Flu Nighttime Severe Acetaminophen / Pain Reliever/Fever Reducer Dextromethorphan HBr /Cough Suppressant Doxylamine Succinate / Antihistamine Phenylephrine HCl / Nasal Decongestant Relieves: Headache, Fever, Sore Throat, Minor Aches & Pains, Nasal Congestion, Sinus Pressure, Sneezing, Runny Nose, Cough compare to Vicks ® NyQuil ® VapoCOOL™ SEVERE Cold & Flu + Congestion active ingredients* 16 CAPLETS Actual Size [caplet image]

Source Document#

Source XML