Indications and uses
temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • sore throat n headache n minor aches and pains • fever • runny nose and sneezing
Nightime Cold and Flu
- Manufacturer
- Meijer, Inc.
- Effective date
- 2024-12-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 00:48:01
Label at a glance#
ProductNightime Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure9 sections
Dosage and administration
take only as directed - see Overdose warning. do not exceed 4 doses per 24 hours adults & children 12 years & 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 ensure correct dosing
Storage and handling
• store between 15°C to 30°C (59°F to 86°F) • avoid excessive heat
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 15 mg
Doxylamine succinate 6.25 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
temporarily relieves common cold/flu symptoms:
• cough due to minor throat and bronchial irritation
• sore throat n headache n 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 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
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, lasts for more than 2 days, or occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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
• 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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin.
OTC - WHEN USING SECTION
When using this product
• do not use more than directed
• excitability may occur, especially in children
• marked drowsiness may occur n avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives and tranquilizers may increase drowsiness
OTC - STOP USE SECTION
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
• redness or swelling is present
• new symptoms occur
• 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.
OVERDOSAGE SECTION
Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.
Directions
- take only as directed - see Overdose warning.
- do not exceed 4 doses per 24 hours
| adults & children 12 years & 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 ensure correct dosing
Other information
• store between 15°C to 30°C (59°F to 86°F)
• avoid excessive heat
Inactive Ingredients
D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, lecithin, myglyol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
Questions or comments?
1-888-333-9792
Principal Display Carton
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 | 6 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 6 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 6 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 79481-0027-2 | Nightime Cold and Flu | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 6 | |
| 79481-0027-2 | Nightime Cold and Flu | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 79481-0027 | NIGHTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MEIJER, INC.] | 6 | Legacy NDC, 2 package rows | 20241222_eac91dcf-ff2a-4131-9fca-c12af71d757e.zip |
Products#
Every source-derived product name is available through these pages.
- Nightime Cold and Flu
- Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate
- FD&C BLUE NO. 1
- GELATIN
- GLYCERIN
- LECITHIN, SOYBEAN
- POLYETHYLENE GLYCOL 400
- POVIDONE
- PROPYLENE GLYCOL
- SORBITOL
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- D&C YELLOW NO. 10
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 79481-0027 | 79481-0027-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| D&C YELLOW NO. 10 | 35SW5USQ3G | 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 |
|---|---|---|---|---|---|---|
| 29baa37a-1222-d45b-e063-6294a90a12c4 | eac91dcf-ff2a-4131-9fca-c12af71d757e | 2024-12-20 | Warnings | 29baa37a-1222-d45b-e063-6294a90a12c4 eac91dcf-ff2a-4131-9fca-c12af71d757e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.