DAY-NIGHT COLD AND FLU
- Manufacturer
- TARGET CORP | TIME CAP LABS INC | MARKSANS PHARMA LTD
- Effective date
- 2020-12-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:41:39
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
DAY COLD AND FLU RELIEF
Active ingredients (in each SOFTGEL)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
INACTIVE INGREDIENT SECTION
Inactive ingredients: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
OTC - PURPOSE SECTION
Purposes:
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
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
INDICATIONS & USAGE SECTION
Pain Reliever-Fever Reducer
Cough Suppressant
Antihistamine
Nasal Decongestant
Nasal Congestion
Headache & Body Ache
Cough
Runny Nose
Sore Throat
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 alcoholic drinks every day while using this product
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.
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(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.
NIGHT COD AND FLU RELIEF
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
DOSAGE & ADMINISTRATION SECTION
DOSAGE & ADMINISTRATION
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
INDICATIONS & USAGE SECTION
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
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.
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11673-947-24 | 2025-02-15 | C162847 | 48780-1 | 2cef2736-7f96-d83d-e063-dadaa90ab31f | 634T TARGET DAY-NIGHT COLD AND FLU RELIEF 11693-947 |
| 11673-947-24 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-7f96-d83d-e063-dadaa90ab31f | 634T TARGET DAY-NIGHT COLD AND FLU RELIEF 11693-947 |
Products#
Every source-derived product name is available through these pages.
- DAY-NIGHT COLD AND FLU
- DAY-NIGHT COLD FLU
- NIGHT COLD AND FLU RELIEF
- ACETAMINOPHEN,
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- TITANIUM DIOXIDE
- FD&C BLUE NO. 1
- GELATIN
- ACETAMINOPHEN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- WATER
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GLYCERIN
- PROPYLENE GLYCOL
- SHELLAC
- SORBITOL SOLUTION
- DAY COLD AND FLU RELIEF
- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL
- FD&C YELLOW NO. 6
- FD&C RED NO. 40
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11673-947 | 11673-947-24 |
| 11673-946 | 11673-946-08 |
| 11673-945 | 11673-945-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f1fb786e-49d8-5e6f-e053-2a95a90ab766 | 9e01e8d0-31c6-c2c0-e053-2995a90a1f58 | 2025-02-15 | Warnings | 9e01e8d0-31c6-c2c0-e053-2995a90a1f58 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
