Maximum strength Day cold and flu and Night severe cold and flu
- Manufacturer
- TIME CAP LABORATORIES,INC | MARKSANS PHARMA LIMITED
- Effective date
- 2023-09-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:57:10
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each caplet)
Day Cold & Flu
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Active ingredients (in each caplet)
Night Severe Cold & Flu
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Triprolidine HCl 1.25 mg
OTC - PURPOSE SECTION
Purposes
Day Cold & Flu
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Purposes
Night Severe Cold & Flu
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Antihistamine
INDICATIONS & USAGE SECTION
Uses
Day Cold & Flu
• temporarily relieves these common cold and flu symptoms:
o cough
o nasal congestion
o minor aches and pains
o sore throat
o headache
o stuffy nose
o sinus congestion and pressure
• temporarily reduces fever
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Night Severe Cold & Flu
• temporarily relieves these common cold and flu symptoms:
o cough
o nasal congestion
o minor aches and pains
o sore throat
o headache
o sneezing
o sinus congestion and pressure
o runny nose
o itching of the nose or throat
o itchy, watery eyes due to hay fever
• temporarily reduces fever
• controls cough to help you get to sleep
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 4,000 mg in 24 hours, which is the maximum daily amount
• 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
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.
OTC - DO NOT USE SECTION
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
• liver disease
• heart disease
• diabetes
• high blood pressure
• thyroid disease
• glaucoma
(Night Severe Cold & Flu only)
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
(Night Severe Cold & Flu only)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers
(Night Severe Cold & Flu only)
OTC - WHEN USING SECTION
When using this product
• do not use more than directed
• excitability may occur, especially in children
(Night Severe Cold & Flu only)
• marked drowsiness may occur
(Night Severe Cold & Flu only)
• alcohol, sedatives, and tranquilizers may increase drowsiness
(Night Severe Cold & Flu only)
• avoid alcoholic drinks
(Night Severe Cold & Flu only)
• use caution when driving a motor vehicle or operating machinery
(Night Severe Cold & Flu only)
OTC - STOP USE SECTION
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
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.
DOSAGE & ADMINISTRATION SECTION
Directions
Day Cold & Flu
•
do not take more than directed (see Overdose warning)
• do not take more than 12 caplets in any 24-hour period
• adults and children 12 years of age and over: take 2 caplets every 4 hours
• children under 12 years of age: do not use
Night Severe Cold & Flu
• do not take more than directed (see Overdose warning)
• do not take more than 8 caplets in any 24-hour period
• adults and children 12 years of age and over: take 2 caplets every 4 hours
• children under 12 years of age: do not use
OTHER SAFETY INFORMATION
Other information
- store at 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients Day Cold & Flu
colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
Inactive ingredients Night Severe Cold & Flu
colloidal silicon dioxide, croscarmellose sodium, mica, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, talc, titanium dioxide, yellow iron oxide
OTC - QUESTIONS SECTION
Questions or Comments?
Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2560237 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral Tablet) } Pack | GPCK | 1 |
| 2560237 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral Tablet) Pack | PSN | 1 |
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 1 |
| 2549037 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral Tablet | PSN | 1 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 1 |
| 2549037 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral Tablet | SCD | 1 |
| 2560237 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral Tablet) Pack | SY | 1 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 1 |
| 2549037 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral Tablet | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49483-726-64 | Maximum strength Day cold and flu and Night severe cold and flu | 4 in 1 CARTON | KIT | 4 | 1 | |
| 49483-726-64 | Maximum strength Day cold and flu and Night severe cold and flu | 1 in 1 BLISTER PACK | KIT | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49483-726 | MAXIMUM STRENGTH DAY COLD AND FLU AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETS) KIT [TIME CAP LABORATORIES,INC] | 1 | Current NDC, 2 package rows | 20231021_fff69901-965c-5372-e053-6394a90a29c2.zip |
Products#
Every source-derived product name is available through these pages.
- Maximum strength Day cold and flu and Night severe cold and flu
- Acetaminophe, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Triprolidine HCl Tablets
- Maximum Strength Day Cold and Flu
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl Tablets
- CROSCARMELLOSE SODIUM
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POVIDONE
- TITANIUM DIOXIDE
- TALC
- SILICON DIOXIDE
- CROSPOVIDONE, UNSPECIFIED
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- Maximum Strength Night Severe Cold and Flu
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Triprolidine HCl Tablets
- MICA
- TRIPROLIDINE HYDROCHLORIDE
- TRIPROLIDINE
- STEARIC ACID
- FERRIC OXIDE YELLOW
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49483-726 | 49483-726-64 |
| 49483-733 | |
| 49483-734 |
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 |
|---|---|---|---|---|---|---|
| Maximum strength Day cold and flu and Night severe cold and flu | ACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETS | TIME CAP LABORATORIES,INC | fff69901-965c-5372-e053-6394a90a29c2 | 2023-09-18 | Warnings | 49483-726-64 49483-726 49483072664 fff69901-965d-5372-e053-6394a90a29c2 fff69901-965c-5372-e053-6394a90a29c2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
