Non-Drowsy Max Cold

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2023-12-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:04:31

Key Label Information#

Active Ingredients And Purpose

Active ingredients

Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCI 5 mg

Purpose

Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant

Uses

Uses

Uses temporary relieves these common cold and flu symptoms: minor aches and pains nasal congestion headache cough sinus congestion and pressure sore throat helps clear nasal passages promotes nasal and sinus drainage temporarily reduces fever

Warnings

Warnings

Directions And Dosage

Directions

Directions do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor

Other Label Information

Other information

Other information 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 ingredients corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

Questions or comments? call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

PDP/Package

TEMPORARILY RELIEVES COLD/FLU SYMPTOMS Compare to the active ingredients in Tylenol® Cold Max* CIRCLE K™ non-drowsy max cold Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant [caplet image] actual size 6 caplets

Label Images#

56283 CK Max Cold_paint
56283 CK Max Cold_paint

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094538acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral TabletPSN2
1094538acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD2
1094538APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-5628-3Non-Drowsy Max Cold3 in 1 CARTONTABLET, FILM COATED32
66715-5628-3Non-Drowsy Max Cold2 in 1 BLISTER PACKTABLET, FILM COATED22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-5628NON-DROWSY MAX COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI TABLET, FILM-COATED) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2Current NDC, Legacy NDC, 2 package rows20231215_e79f1a92-d8ea-e3f9-e053-2a95a90a2d37.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-562866715-5628-3

Ingredients#

Complete SPL Sections#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCI 5 mg

Purpose

OTC - PURPOSE SECTION

Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Uses temporary relieves these common cold and flu symptoms: minor aches and pains nasal congestion headache cough sinus congestion and pressure sore throat helps clear nasal passages promotes nasal and sinus drainage temporarily reduces fever

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Directions do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

Other information 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 corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments? call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Tamper evident statement

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING

PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TEMPORARILY RELIEVES COLD/FLU SYMPTOMS Compare to the active ingredients in Tylenol® Cold Max* CIRCLE K™ non-drowsy max cold Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant [caplet image] actual size 6 caplets

Source Document#

Source XML