MAXIMUM STRENGTH NIGHTTIME 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 23:21:48

Label at a glance#

ProductMAXIMUM STRENGTH NIGHTTIME COLD AND FLU
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

  • Acetaminophen 325 mg
  • Dextromethorphan HBr 10 mg
  • Doxylamine succinate 6.25 mg
  • Phenylephrine HCl 5 mg

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose

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

INDICATIONS & USAGE SECTION

  • temporarily relieves common cold/flu symptoms:

nasal congestion, cough, nasal congestion, minor aches and pains, sore throat, headache, runny nose and sneezing

  • temporarily reduces fever
  • controls cough to help you get to sleet

DOSAGE & ADMINISTRATION SECTION

Directions -Do not take more than directed (see Overdose warning)

  • do not exceed more than 8 softgels in any 24 hr- period -
  • adults & children 12 yrs & older: take 2 Softgels every 4 hrs
  • children under 12 yrs of age - Do not use.

WARNINGS SECTION

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

  • more than 8 Softgels in 24 hours, which is the maximum daily amount for this product
  • 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

Sore troat 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.

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 (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

8 ct8 ct

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-97911673-979-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2d004249-e006-72fa-e063-6394a90a14c19dff2418-031c-1308-e053-2995a90accb42025-02-15WarningsExact identifier
spl set id: 9dff2418-031c-1308-e053-2995a90accb4

Reported adverse events (FAERS/openFDA)#

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