FDA.reportPublic FDA data

MAXIMUM STRENGTH DAYTIME - NIGHTTIME COLD AND FLU COLD AND FLU

Manufacturer
TARGET CORP | TIME CAP LABS INC | MARKSANS PHARMA LTD
Effective date
2020-07-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:22:50

Label at a glance#

ProductMAXIMUM STRENGTH DAYTIME - NIGHTTIME COLD AND FLU COLD AND FLU
Active ingredientGUAIFENESIN, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each softgel)

ACETAMINOPHEN 325MG

DEXTROMETHORHAN HBR10 MG,

GUAIFENESIN 200 MG

, PHENYLEPHRINE HCL 5 MG

INDICATIONS & USAGE SECTION

  • temporarily relieves common cold/flu symptoms: nasal congestion,headache, cough, minor aches and pains, sore throat
  • temoporarily reducces fever
  • prootes nasal and/or sinus drainage
  • helps ollsen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNINGS SECTION

Warnings
Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take - more than 8sogtgels

This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 8 Softgels in 24 hrs, 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.

INACTIVE INGREDIENT SECTION

FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide

DOSAGE & ADMINISTRATION SECTION

Do not take more than directed (See Overdose warning section) - do not exceed 12 Softgels per 24 hr period

  • adults & children 12 yrs & over 2 Softgels every 4 hrs
  • children 4 to under 12 yrs: Do not use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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 Center right away. (1800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

OTC - PURPOSE SECTION

PAIN RELIEVER-FEVER REDUCER

COUGH SUPPRESENT

MINOR ACHES AND PAINS

CHEST CONGESTION

OTC - ACTIVE INGREDIENT SECTION


(in each softgel)
Acetaminophen 325mg

Dextromethorphan HBR 10 mg

Doxylamine Succinate 6.25 mg

PhenylephrineHCl 5mg

INDICATIONS & USAGE SECTION

Purpose

  • Pain reliever/Fever reducer
  • Cough suppressant
  • Antihistamine
  • Nasal decongestant

OTC - PURPOSE SECTION

MINOR ACHES AND PAINS, FEVER

NASAL CONGESTION AND SINUS PRESSURE

SNEEZING, RUNNY NOSE

COUGH

OTC - PURPOSE SECTION

PAIN RELIEVER-FEVER REDUCER

COUGH SUPPRESENT

MINOR ACHES AND PAINS

NASAL DECONGESTION

WARNINGS SECTION

Warnings
Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 softgels in 24 hrs, 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.

DOSAGE & ADMINISTRATION SECTION

Directions
take only as directed - do not exceed 8 softgels per 24 hours -

adults & children 12 yrs & over 2 softgels with water every 6 hrs -

children 4 to under 12 yrs ask a doctor -

children under 4 yrs do not use

INACTIVE INGREDIENT SECTION

FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

24 COMBO24 COMBO

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11673-925-242025-02-15C16284748780-12cef2736-7524-d83d-e063-dadaa90ab31fTARGET MAX STRENGTH COLD AND FLU DAYTIME-NIGHTTIME 11673-925
11673-925-242025-01-30C16284748780-12cef2736-7524-d83d-e063-dadaa90ab31fTARGET MAX STRENGTH COLD AND FLU DAYTIME-NIGHTTIME 11673-925

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-92511673-925-24
11673-978
11673-979

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
GELATIN2G86QN327LIACT
SHELLAC46N107B71OIACT
POVIDONEFZ989GH94EIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GUAIFENESIN495W7451VQACTIB
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
ACETAMINOPHEN362O9ITL9DACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
GLYCERINPDC6A3C0OXIACT
ACETAMINOPHEN362O9ITL9DACTIB
GELATIN2G86QN327LIACT
SHELLAC46N107B71OIACT
SORBITOL506T60A25RIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT
POVIDONEFZ989GH94EIACT

Source Document#

Source XML

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORP9dfef3dc-dbc8-659a-e053-2995a90a8c3b2025-05-21WarningsExact identifier
ndc (product): 11673-978
f1fa7f51-92f6-fd58-e053-2a95a90aeec79dff3771-c4c2-bd63-e053-2995a90acfd82025-02-15WarningsExact identifier
spl set id: 9dff3771-c4c2-bd63-e053-2995a90acfd8

Reported adverse events (FAERS/openFDA)#

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