Indications and uses
Temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation minor aches and pains fever runny nose and sneezing sore throat headache
NIGHTTIME COLD AND FLU
- Manufacturer
- We Care Distributor Inc. | Softech Pharma Pvt. Ltd
- Effective date
- 2016-03-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-05-31 22:45:13
Label at a glance#
ProductNIGHTTIME COLD AND FLU
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure9 sections
Dosage and administration
take only as directed - see Liver warning do not exceed 8 softgels per 24 hours adults and children 12 years and over: 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 other Daytime or Nighttime products, carefully read each label to insure correct dosing
Storage and handling
store at 20º-25ºC (68º-77ºF) read all product information before using. Keep this box for important information
Contacts and useful links#
Websitewww.wecaredistributor.com
www.wecaredistributor.com
www.wecaredistributor.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active Ingredient (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/flu symptoms:
- cough due to minor throat and bronchial irritation
- minor aches and pains
- fever
- runny nose and sneezing
- sore throat
- headache
Warnings
Liver warning:
This product contains acetaminophen. The maximum daily dose of this product is 8 softgels (2,600 mg acetaminophen) in 24 hours. 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
Sore throat warning:
If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly
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 monomine 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.
- to make a child sleepy
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- gloucoma
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking sedative or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- excitability may occur, especially in children
- be careful when driving a motor vehicle or operating machinery
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- may cause marked drowsiness
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
- cough comes back or occurs with 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.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 Liver warning
do not exceed 8 softgels per 24 hours
adults and children 12 years and over: 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 other Daytime or Nighttime products, carefully read each label to insure correct dosing
Other information
store at 20º-25ºC (68º-77ºF)
- read all product information before using. Keep this box for important information
Inactive ingredients
D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, methylparaben, polyethylene glycol, povidone, propylene glycol, propylparaben, purified water, sorbitol special, sorbitol solution, titanium dioxide
Questions or comments?
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
PRINCIPAL DISPLAY PANEL
See New Warnings Information & Directions
Compare to the Active Ingredients in
NyQuil® LiquiCaps®
Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate 325 mg, 15 mg and 6.25 mg
TO OPEN
PUSH IN TAB AND PULL OUT
25 Pouches of 2 Softgels Each
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 | 7 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 7 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 7 |
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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70005-005-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3247-f424-e053-dadaa90a57ce | NIGHTTIME COLD AND FLU - Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate |
| 70005-005-25 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3247-f424-e053-dadaa90a57ce | NIGHTTIME COLD AND FLU - Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate |
| 70005-005-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3247-f424-e053-dadaa90a57ce | NIGHTTIME COLD AND FLU - Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70005-005-02 | NIGHTTIME COLD AND FLU | 2 in 1 POUCH | CAPSULE, LIQUID FILLED | 2 | 7 | |
| 70005-005-25 | NIGHTTIME COLD AND FLU | 2 in 1 POUCH | CAPSULE, LIQUID FILLED | 2 | 7 | |
| 70005-005-25 | NIGHTTIME COLD AND FLU | 25 in 1 BOX | CAPSULE, LIQUID FILLED | 25 | 7 | |
| 70005-005-50 | NIGHTTIME COLD AND FLU | 50 in 1 BOX | CAPSULE, LIQUID FILLED | 50 | 7 | |
| 70005-005-50 | NIGHTTIME COLD AND FLU | 2 in 1 POUCH | CAPSULE, LIQUID FILLED | 2 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70005-005 | NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE 325 MG, 15 MG AND 6.25 MG) CAPSULE, LIQUID FILLED [WE CARE DISTRIBUTOR INC.] | 7 | Legacy NDC, 5 package rows | 20160301_a1964f27-6224-4a56-8f2d-3035db1f4a8b.zip |
Products#
Every source-derived product name is available through these pages.
- NIGHTTIME COLD AND FLU
- Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate 325 mg, 15 mg and 6.25 mg
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- GELATIN
- GLYCERIN
- METHYLPARABEN
- POLYETHYLENE GLYCOL 1000
- POVIDONE
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SORBITOL
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70005-005 | 70005-005-25, 70005-005-50, 70005-005-02 |
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 |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | 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 |
|---|---|---|---|---|---|---|
| abbdacdc-1646-45bf-99ed-9e3fd94b78b6 | a1964f27-6224-4a56-8f2d-3035db1f4a8b | 2016-03-01 | Warnings | abbdacdc-1646-45bf-99ed-9e3fd94b78b6 a1964f27-6224-4a56-8f2d-3035db1f4a8b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.