Indications and uses
temporarily relieves common cold and flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing
Tukol Night Time Cold and Flu Relief Softgels
- Manufacturer
- Genomma Lab USA
- Effective date
- 2023-01-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:53:13
Label at a glance#
ProductTukol Night Time Cold and Flu Relief Softgels
Active ingredientAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate
Label structure10 sections
Dosage and administration
take only as directed (see Warnings ) do not exceed 4 doses per 24 hours Adults and children 12 years and over: take 2 softgels with water every 6 hours Children 4 to under 12 years: Ask a doctor Children under 4 years: Do not use When using Day Time or Night Time products, carefully read each label to ensure correct dosing
Storage and handling
store at room temperature 20-25°C (68-77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each softgel) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 15 mg | Cough suppressant |
| Doxylamine succinate 6.25 mg | Antihistamine |
Uses
temporarily relieves common cold and flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
- runny nose and sneezing
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash If 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.
Do not use
- with any other products 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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- to make a child sleep
Ask a doctor before use if you have
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drink
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 7 days
- fever gets worse or last more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts
- a skin reaction occurs. 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. In case of accidental 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.
Directions
- take only as directed (see Warnings)
- do not exceed 4 doses per 24 hours
Adults and children 12 years and over: take 2 softgels with water every 6 hours
Children 4 to under 12 years: Ask a doctor
Children under 4 years: Do not use - When using Day Time or Night Time products, carefully read each label to ensure correct dosing
Other information
- store at room temperature 20-25°C (68-77°F)
Inactive Ingredients
FD&C Blue #1, D&C Yellow #10, Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol, Purified water, Sorbitol sorbitan solution, Titanium dioxide.
Questions or comments?
Call toll free 1-877-994-3666
Weekdays from 8 am to 6 pm
SPL UNCLASSIFIED SECTION
Distributed by
Genomma Lab USA, Inc.
Houston, TX 77098
PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton
NEW
Tukol®
NIGHT TIME
COLD AND FLU RELIEF
Acetaminophen / Dextromethorphan HBr /
Doxylamine succinate
- COUGH
- RUNNY NOSE
- SORE THROAT
- ACHES
- NASAL CONGESTION
- FEVER
24
Softgels
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 1 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 1 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50066-311-24 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-6ee5-d83d-e063-dadaa90ab31f | Tukol ® Night Time Cold and Flu Relief Softgels |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50066-311-24 | Tukol Night Time Cold and Flu Relief Softgels | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 1 | |
| 50066-311-24 | Tukol Night Time Cold and Flu Relief Softgels | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50066-311 | TUKOL NIGHT TIME COLD AND FLU RELIEF SOFTGELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [GENOMMA LAB USA] | 1 | Legacy NDC, 2 package rows | 20230113_57ab72e4-75f9-4044-bdc7-d515fdcc0116.zip |
Products#
Every source-derived product name is available through these pages.
- Tukol Night Time Cold and Flu Relief Softgels
- Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate
- Acetaminophen
- Dextromethorphan Hydrobromide
- Dextromethorphan
- Doxylamine succinate
- Doxylamine
- gelatin, unspecified
- glycerin
- polyethylene glycol, unspecified
- povidone, unspecified
- propylene glycol
- water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50066-311 | 50066-311-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Acetaminophen | 362O9ITL9D | ACTIB |
| Dextromethorphan Hydrobromide | 9D2RTI9KYH | ACTIB |
| Doxylamine succinate | V9BI9B5YI2 | ACTIB |
| gelatin, unspecified | 2G86QN327L | IACT |
| glycerin | PDC6A3C0OX | IACT |
| polyethylene glycol, unspecified | 3WJQ0SDW1A | IACT |
| povidone, unspecified | FZ989GH94E | IACT |
| propylene glycol | 6DC9Q167V3 | IACT |
| water | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| 2de4de60-b5c8-4933-9dab-e47321b8f799 | 57ab72e4-75f9-4044-bdc7-d515fdcc0116 | 2023-01-10 | Warnings | 2de4de60-b5c8-4933-9dab-e47321b8f799 57ab72e4-75f9-4044-bdc7-d515fdcc0116 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.