NIGHT COLD AND FLU RELIEF

Manufacturer
TARGET CORP | TIME CAP LABS INC | MARKSANS PHARMA LTD
Effective date
2020-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:41:39

Label at a glance#

ProductNIGHT COLD AND FLU RELIEF
Active ingredientDOXYLAMINE SUCCINATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredeints in each softgel

ACETAMINOPHEN 325 mg

Dextromethorphan Hydrobromide 10 mg

Doxylamine Succinate 6.25 mg

Phenylephrine HCl 5 mg

INACTIVE INGREDIENT SECTION

Inactive ingredients: FD&C Blue #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

INDICATIONS & USAGE

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache · cough

· sore throat · nasal and sinus congestion

· temporarily reduces fever

DOSAGE & ADMINISTRATION SECTION

Directions

· do not take more than the recommended dose

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 10 capsules in 24 hours or as

directed by a doctor.

· children under 12 years: do not use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

WARNINGS SECTION

Warnings

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

· more than 4,000 mg of acetaminophen in 24 hours

· with other drugs containing acetaminophen

· 3 or more aloholic drinks every day while using this product

l Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general allergic 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8 count8 count

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
11673-94611673-946-08

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
2e2a572b-dcce-5683-e063-6394a90ac18e9e01ce3b-b6a9-145b-e053-2a95a90ad8922025-02-15WarningsExact identifier
spl set id: 9e01ce3b-b6a9-145b-e053-2a95a90ad892

Reported adverse events (FAERS/openFDA)#

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