FDA.reportPublic FDA data

Target Maximum Strength Cold Flu and Sore Throat

Manufacturer
TARGET CORPORATION
Effective date
2025-11-05
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:42:16

Label at a glance#

ProductTarget Maximum Strength Cold Flu and Sore Throat Overnight Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

MAXIMUM STRENGTH COLD, FLU & SORE THROAT temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache stuffy nose sinus congestion and pressure temporarily reduces fever temporarily promotes nasal and for sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more pro...

Dosage and administration

do not take more than directed (see Overdose warning) do not take more than 6 doses in any 24- hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours children under 12 years of age: Do not use

Storage and handling

each 20 mL contains: sodium 8 mg store at room temperature do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 20 mL)
MAXIMUM STRENGTH ‡COLD, FLU & SORE THROAT 		Purposes

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Pain reliever/fever reducer

Cough suppressant

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Expectorant

Nasal decongestant

Active ingredients (in each 20 mL)Purposes
MAXIMUM STRENGTH OVERNIGHT COLD & FLU

Acetaminophen 650 mg

Pain reliever/fever reducer

Dextromethorphan HBr 20 mg

Triprolidine HCl 2.5 mg

Cough suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

MAXIMUM STRENGTH COLD, FLU & SORE THROAT

  • temporarily relieves these common cold and flu symptoms:
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • stuffy nose
  • sinus congestion and pressure
  • temporarily reduces fever
  • temporarily promotes nasal and for sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Liver warnings:This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than6 doses in 24 hours which is the maximum daily amount
  • 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 warnings: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.

Do not use

OTC - DO NOT USE SECTION

  • 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.

Overdose warnings.

OVERDOSAGE SECTION

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you don’t notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see Overdose warning)
  • do not take more than 6 doses in any 24- hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter
  • adults and children 12 years of age and over:20 mL in dosing cup provided every 4 hours
  • children under 12 years of age:Do not use

Other information

STORAGE AND HANDLING SECTION

  • each 20 mL contains:sodium 8 mg
  • store at room temperature
  • do not refrigerate

Inactive ingredients (Maximum strength Cold, Flu and Sore Throat)

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, FD&C Blue No.1, FD&C Red No. 40, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Uses (OVERNIGHT COLD & FLU

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
  • cough
  • minor aches and pains
  • sore throat
  • headache
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep

Warnings

WARNINGS SECTION

Liver warnings:This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4000 mg in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning:Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Centre right away at 1-800-222-1222.

Quick medical attention is critical for adults as well as for children, even if you do not notice any signs

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warnings
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and over:20 ml in dosing cup provided every 4 hours
  • children under 12 years of age:do not use
Other Information

OTHER SAFETY INFORMATION

  • each 20 mL contains:sodium 10 mg
  • low sodium
  • store at room temperature
  • do not refrigerate

Inactive ingredients (Overnight Cold & Flu)

INACTIVE INGREDIENT SECTION

anhydrous citric acid, ascorbic acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose and xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

(1-866-467-2748)

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUE PACK

NDC 11673-691-12

Compare to active ingredients Maximum Strength ‡Mucinex® Fast Max® Cold, Flu and Sore Throat

Maximum Strength ‡

Cold, Flu and Sore Throat

Acetaminophen• Pain Reliever/Fever Reducer

Dextromethorphan HBr • Cough Suppressant
Guaifenesin • Expectorant

Phenylephrine HCl • Nasal Decongestant

  • Controls Cough, Thins & Loosens Mucus
  • Nasal & Chest Congestion
  • Sinus pressure & Congestion
  • Body Pain, Headache, Fever & Sore Throat

*Per 4-hour dose

For Ages 12+

6 FL. OZ. (180 mL)

*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore Throat.

Compare to Mucinex® Nightshift Cold, Flu & Sore Throat Active Ingredients**

Overnight Cold & Flu

Acetaminophen• Pain Reliever/Fever Reducer
Dextromethorphan HBr • Cough Suppressant

Triprolidine HCl • Antihistamine

Night Time Relief for a Better Morning

Maximum Strength per 4-hour dose

  • Cough
  • Fever
  • Sore Throat
  • Runny Nose
  • Sneezing

For Ages 12+

6 FL OZ (180 mL)

**This product is not manufactured or distributed by RB Health, the distributor of Mucinex® Nightshift Cold & Flu.

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING.

See bottle for full labeling

Distributed by:

094 14 8715 R00

C-001227-01-055

Dist. By Target Corp.

Mpls., MN 55403

TM & © 2020

Target Brands, Inc.

Questions?

Cal 1-866-467-2748

DO NOT TAKE MAXIMUM STRENGTH COLD, FLU & SORE THROAT & OVERNIGHT COLD & FLU LIQUIDS AT THE SAME TIME.

Target Max Strength Value Pack Cold and Flu Relief
Target Max Strength Value Pack Cold and Flu Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2637729{1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) } PackGPCK7
26377291 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) / 1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine hydrochloride 10 MG in 20 mL Oral Solution) PackPSN7
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSN7
2173667acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral SolutionPSN7
1116572acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD7
2173667acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral SolutionSCD7
26377291 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) / 1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution) PackSY7
1116572acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY7
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSY7
2173667acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral SolutionSY7
1116572APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY7
2173667APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral SolutionSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11673-691-122024-04-17C16284748780-11030e365-5499-111a-e063-dadaa90a10e2Maximum Strength Cold, Flu & Sore Throat and Overnight Cold & Flu Value Pack
11673-691-122024-04-17C16284748780-11030e365-5499-111a-e063-dadaa90a10e2Maximum Strength Cold, Flu & Sore Throat and Overnight Cold & Flu Value Pack
11673-691-122024-01-30C16284748780-11030e365-5499-111a-e063-dadaa90a10e2Maximum Strength Cold, Flu & Sore Throat and Overnight Cold & Flu Value Pack
11673-691-122024-01-30C16284748780-11030e365-5499-111a-e063-dadaa90a10e2Maximum Strength Cold, Flu & Sore Throat and Overnight Cold & Flu Value Pack

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-691-12Target Maximum Strength Cold Flu and Sore ThroatOvernight Cold and Flu1 in 1 CARTONKIT17
82442-698-06Target Maximum Strength Cold Flu and Sore ThroatOvernight Cold and Flu180 mL in 1 BOTTLESOLUTION180 mL650 mg in 20mL7
82442-737-06Target Maximum Strength Cold Flu and Sore ThroatOvernight Cold and Flu180 mL in 1 BOTTLESOLUTION180 mL400 mg in 20mL7

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-69111673-691-12
82442-73782442-737-06
82442-69882442-698-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
POTASSIUM CITRATEEE90ONI6FFIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYL GALLATE8D4SNN7V92IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
TRIPROLIDINE HYDROCHLORIDEYAN7R5L890ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-11-08full-release2026-06-01 00:35:39

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Maximum Strength Cold Flu and Sore Throat Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND TRIPROLIDINE HCLTARGET CORPORATION6e94fdab-27ea-4c0f-a91c-735ce697304b2025-11-05WarningsExact identifier
ndc (package): 82442-737-06
ndc (package): 82442-698-06
ndc (package): 11673-691-12
ndc (product): 11673-691
ndc11 (package): 82442069806
ndc11 (package): 82442073706
ndc11 (package): 11673069112
spl id: 42d73566-a484-e5ad-e063-6394a90a08af
spl set id: 6e94fdab-27ea-4c0f-a91c-735ce697304b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.