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#
Contacts and useful links#
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)
|
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11673-979-08 | 2025-02-15 | C162847 | 48780-1 | 2cef2736-7c4f-d83d-e063-dadaa90ab31f | TARGET 11673-979 MAX STRENGTH NIGHTTIME COLD AND FLU |
| 11673-979-08 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-7c4f-d83d-e063-dadaa90ab31f | TARGET 11673-979 MAX STRENGTH NIGHTTIME COLD AND FLU |
Products#
Every source-derived product name is available through these pages.
- MAXIMUM STRENGTH NIGHTTIME COLD AND FLU
- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ACETAMINOPHEN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- FD&C BLUE NO. 1
- GELATIN
- POVIDONE
- PROPYLENE GLYCOL
- POLYETHYLENE GLYCOL, UNSPECIFIED
- WATER
- SORBITOL
- GLYCERIN
- SHELLAC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11673-979 | 11673-979-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SHELLAC | 46N107B71O | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
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 |
|---|---|---|---|---|---|---|
| 2d004249-e006-72fa-e063-6394a90a14c1 | 9dff2418-031c-1308-e053-2995a90accb4 | 2025-02-15 | Warnings | 9dff2418-031c-1308-e053-2995a90accb4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
