Indications and uses
temporarily relieves common cold/flu symptoms: fever headache minor aches and pain cough due to minor throat and bronchial iffitation sore throat nasal congestion (Daytime only) runny nose and sneezing (Nighttime only)
Cold and Flu Non Drowsy Daytime and Nighttime
- Manufacturer
- Meijer, Inc.
- Effective date
- 2024-12-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 00:47:53
Label at a glance#
ProductCold and Flu Non Drowsy Daytime and Nighttime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure9 sections
Dosage and administration
● when using other DAYTIME and NIGHTTIME products, carefully read each label to ensure correct dosing Directions (Daytime only) ● take only as directed - see Overdose warning ● do not exceed 4 doses per 24 hours adults & children 12 years & over take 2 softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years of age do not use ● when using other DAYTIME and NIGHTTIME produ...
Storage and handling
store at room temperature.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each softgel)
COLD & FLU NON-DROWSY DAY RELIEF
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
COLD & FLU NIGHT RELIEF
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Purposes
COLD & FLU NON DROWSY DAY RELIEF
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
COLD & FLU NIGHT RELIEF
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
temporarily relieves common cold/flu symptoms:
- fever
- headache
- minor aches and pain
- cough due to minor throat and bronchial iffitation
- sore throat
- nasal congestion (Daytime only)
- runny nose and sneezing (Nighttime only)
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 every day 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.
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.● if you have ever had an allergic reaction to this product or any of its ingredients● to make a child sleepy (Nighttime only)
Ask a doctor before use if you have
● cough that occurs with too much phlegm (mucus) ● liver disease
● trouble urinating due to enlarged prostate gland
● diabetes (Daytime only) ● heart disease (Daytime only)
● thyroid disease (Daytime only) ● high blood pressure (Daytime only)
● persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
● a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
● glaucoma (Nighttime only)
Ask a doctor or pharmacist before use if you are
● taking the blood thinning drug warfarin
● taking sedatives or tranquilizers (Nighttime only)
When using this product
● do not take more than directed
● marked drowsiness may occur (Nighttime only)
● avoid alcoholic drinks (Nighttime only)
● excitability may occur, especially in children (Nighttime only)
● be careful when driving a motor vehicle or operating machinery (Nighttime only)
● alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
Stop use and ask a doctor if
● you get nervous, dizzy or sleepless (Daytime only)
● pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only)
● pain or cough gets worse or lasts more than 7 days (Nighttime only)
● 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 & for children even if you do not notice any signs or symptoms.
Directions
● when using other DAYTIME and NIGHTTIME products, carefully read each
label to ensure correct dosing
Directions (Daytime only)
● take only as directed - see Overdose warning
● do not exceed 4 doses per 24 hours
| adults & children 12 years & over | take 2 softgels with water every 4 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years of age | do not use |
● when using other DAYTIME and NIGHTTIME products, carefully read each label to ensure correct dosing
Directions (Nighttime only)
● take only as directed - see Overdose warning
● do not exceed 4 doses per 24 hours
| adults & children 12 years & over | take 2 softgels with water every 6 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years of age | do not use |
Other information
- store at room temperature.
Inactive ingredients
DAY RELIEF
FD&C Red# 40, FD&C Yellow# 6, gelatin, glycerin, polyethylene glycol, myglyol, lecithin, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
NIGHT RELIEF
D&C Yellow# 10, FD&C Blue# 1, gelatin, glycerin, myglyol, lecithin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, polysorb, sorbitol sorbitan, titanium dioxide
Questions or comments?
1-888-333-9792
Principal Display Panel
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 6 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 6 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 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 |
| PHENYLEPHRINE 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 |
|---|---|---|---|---|---|---|
| 79481-0030-4 | Cold and Flu Non Drowsy Daytime and Nighttime | 1 in 1 CARTON | KIT | 1 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 79481-0030 | COLD AND FLU NON DROWSY DAYTIME AND NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) KIT [MEIJER, INC.] | 6 | Legacy NDC, 1 package rows | 20241222_ce7e397d-a57d-4ae7-94f5-e1c4dfe25ca3.zip |
Products#
Every source-derived product name is available through these pages.
- Cold and Flu Non Drowsy Daytime and Nighttime
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
- Cold and Flu Non Drowsy Day Relief
- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN
- GLYCERIN
- LECITHIN, SOYBEAN
- MEDIUM-CHAIN TRIGLYCERIDES
- POLYETHYLENE GLYCOL 400
- POVIDONE
- PROPYLENE GLYCOL
- SORBITOL
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- Cold and Flu Night Relief
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- SORBITAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 79481-0030 | 79481-0030-4 |
| 79481-0028 | |
| 79481-0029 |
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 |
|---|---|---|---|---|---|---|
| 29ba9c62-8eaa-3ae2-e063-6294a90a4b76 | ce7e397d-a57d-4ae7-94f5-e1c4dfe25ca3 | 2024-12-20 | Warnings | 29ba9c62-8eaa-3ae2-e063-6294a90a4b76 ce7e397d-a57d-4ae7-94f5-e1c4dfe25ca3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.